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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall
| Reference Number: |
mdprc 049 10 11 000 |
| Date submitted: |
10/17/2011 |
| Manufacturer: | Smith & Nephew inc |
| Device Type: | HYSTERSCOPIC BLADE, TRUCLEAR Operative Hysteroscope |
| Description: | HYSTERSCOPIC BLADE |
| Medical Device Identifier: | TRUCLEAR Operative
Hysteroscope, 5.0 - 72202976,
S/N: CCL719400, CCL719401, CCL719402, CCL719403, CCL720650, CCL720651, CCL722944, CCL722946, CCL722947, CCL722949, CCL723401, CCL723404, CCL723409, CCL725430, CCL725432, CCL725433, CCL726485, CCL726488, CCL726489, CCL726490, CCL726491,CCL726493
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| Reason of Field Safety Corrective Action: | when inserting the TRUCLEAR 2.9 mm Blade through the operative portal at the rear of the TRUCLEAR Operative Hysteroscope 5.0, a misalignment of the through-hole in the stopcock valve assembly prevents the passage of the blade into the lumen of the device |
| Remedy Action: | Recall of affected devices undertaken by the manufacturer |
| Athorized Representative/Importer/Distributor: | Smith & Nephew inc, Dubai, 0097144299111 |
| Report Source: | NCAR |
| Source Ref. Number: | UK-2011-10-13-031 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: | No Attachments |
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