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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 099 04 18 000 |
| Date submitted: |
4/22/2018 |
| Manufacturer: | Medtronic |
| Device Type: | Covidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology |
| Description: | Staplers, Surgical, Circular, Hemorrhoid |
| Medical Device Identifier: | 1) EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology 3.5MM:
Item No. HEM3335
Affected Lots: N7J1145MX, N7K0092MX, N7K0692MX, N7K0693MX, N7L0380MX, N7L0457MX, N7L0594MX, N7L0676MX, N7L0762MX, N7L0868MX, N7L0940MX, N7L1076MX, N7L1077MX, N7M0144MX, N7M018SMX, N7M0732MX, N7M0733MX, N7M0835MX, N8A0144MX, N8A0166MX
2) 4.8 mm Covidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology
Item No. : HEM3348
Affected Lots: N7K0694MX, N7L1078MX, N7M0837MX
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| Reason of Field Safety Corrective Action: | This recall is being conducted due to the potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. This issue was identified during in-process Quality testing at the manufacturing facility. There have been no reports of serious injury related to this issue. |
| Remedy Action: | 1. Please quarantine and discontinue use of the affected item code and lots listed on page one.
2. Please return affected product as indicated in Appendix A.
3. Complete the Return Verification Form even if you do not have inventory.
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| Athorized Representative/Importer/Distributor: | Medtronic Saudi Arabia |
| Report Source: | NCMDR |
| Source Ref. Number: | 1CF331F051281 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Medtronic.pdf |
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