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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall
| Reference Number: |
mdprc 021 09 12 000 |
| Date submitted: |
9/3/2012 |
| Manufacturer: | Intuitive Surgical Inc |
| Device Type: | Protector, surgical instrument, Tipp cover Accessory, 8mm MCS |
| Description: | Microsurgical Instruments, Scissors, Surgical, Laparoscopic |
| Medical Device Identifier: | PART NUMBERS: 400180-12;
Tip Cover Accessory Version -12; Lot Nos.:
M10111028, M10111201, M10111208, M10111214, M10120130, M10120207, M10120208, M10120312, M10120315, M10120317, M10120321, M10120329, M10120413, M10120419, M10120426, M10120430, M10120507, M10120510, M10120516, M10120601;
Distributed beginning November 2011 and manufactured before July 27, 2012
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| Reason of Field Safety Corrective Action: | The sealed edge was not formed uniformly, and pleats or creases were formed within the seal area of the pouch. |
| Remedy Action: | 1- Identify and segregate affected product.
2- Work with your Intuitive Surgical Representative to inspect individual Tip Cover pouches.
3- If defective product is identified, destroy and discard the individual pouch, and call Customer Service to receive credit.
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| Athorized Representative/Importer/Distributor: | Gulf Medical Co., Jeddah, (02)6512828 |
| Report Source: | NCAR |
| Source Ref. Number: | CH-2012-08-13-043 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  IntuitiveSurgical (CH-2012-08-13-043).pdf |
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