MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-21 for SC IRIS SCS 4-1/2 CVD 5-SC-306 manufactured by Integra York, Pa Inc..
[47896430]
On 06/02/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - there were two sc iris scissors returned in used condition. One manufactured in jan. 2015 and the other manufactured in march 2015 showing staining, residue, a purple tape marking on one of the handles and both tips broken. Inspected the sc iris scissors and noticed there is blackening at the break area (screw area) and also on the tip of the first one that is broken at the tip, indicating that this started out as a stress fracture and with continued use and cleaning it caused the metal to break down and eventually causing it to break. Not knowing how the scissors were processed/maintained, the complaint is confirmed. Complaint was against one scissors, can't tell which one. Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history: variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: there is no applicable corrective action preventive action history. Health hazard evaluation history: none. Conclusion: root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[47896431]
Customer initially reports device is broken. On (b)(6) 2016 customer reports while cutting a cord during a dental crown, the tip broke off in mouth and was retrieved. No harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00093 |
| MDR Report Key | 5739982 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-21 |
| Date of Report | 2016-05-20 |
| Date Mfgr Received | 2016-06-14 |
| Date Added to Maude | 2016-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SC IRIS SCS 4-1/2 CVD |
| Generic Name | M5 - GENERAL SURGERY |
| Product Code | HNF |
| Date Received | 2016-06-21 |
| Returned To Mfg | 2016-05-26 |
| Catalog Number | 5-SC-306 |
| Lot Number | 100121-1501 & 100121-1503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 2016-06-21 |