MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-11-20 for ROTO-CAM SUPERSCS MON 3.5X24 630202 manufactured by Integra York, Pa Inc..
[93346954]
11/8/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - roto-cam scissors returned in used condition, not showing any unusual markings. There is a yellow tape marking and the hinge at tip is broken. This may happen if too much pressure is used to the tip, when in use. The complaint report is confirmed; damaged worn. Device history evaluation: device history record reviewed and no anomalies found for reported incident.. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[93346955]
Customer initially reports: during the surgery, the customer found that the hinge of the jaw was damaged and came off, though it was the second time use of the device. They are afraid that the parts of the device still remained in patient? S abdomen. (b)(6) 2017 customer reports laparoscopic cholecystectomy being performed. They did x-ray to confirm whether the device is xray transparent or not. No indication that any part was visualized. No harm identified at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00130 |
| MDR Report Key | 7045194 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-11-20 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTO-CAM SUPERSCS MON 3.5X24 |
| Generic Name | 3.5MM ENDOSCOPIC INSTRUMENTATION |
| Product Code | KNF |
| Date Received | 2017-11-20 |
| Returned To Mfg | 2017-11-03 |
| Catalog Number | 630202 |
| Lot Number | 100228-1606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |