MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-13 for CARB EDGE IRIS SCS 4-1/2 CVD 101-301 manufactured by Integra York, Pa Inc..
[24302966]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[24302967]
Customer initially reports the tip of scissor broke off during a case. Doctor was able to obtain piece from patient. Customer said it broke while being used on soft tissue. On (b)(6) 2015 customer reports the doctor was performing a r wrist flexor pollius tongus repair, removal distal radius hardware. No harm done.
Patient Sequence No: 1, Text Type: D, B5
[28348203]
9/15/2015 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - carbide edge iris scissors returned in used condition, not showing any unusual markings. Jarit carb edge iris scissors is showing wear, the tip on both blades of the scissors are chipped/broken. Where the tips are broken off there is blackening. It appears that the scissors may have been dropped or hit something causing the tip to fracture and with continued use and cleaning it caused the metal to break down and eventually causing the tips to break. Device history evaluation - nonconforming product report / nonconforming material report history: none. 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: none. Health hazard evaluation history: none. Conclusion: this complaint is confirmed the root cause is undetermined. No manufacturing deficiency has been found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00064 |
| MDR Report Key | 5011830 |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-22 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-08-18 |
| 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 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 | CARB EDGE IRIS SCS 4-1/2 CVD |
| Generic Name | NA |
| Product Code | FTN |
| Date Received | 2015-08-13 |
| Returned To Mfg | 2015-07-27 |
| Catalog Number | 101-301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-13 |