MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-03-23 for CARB-EDGE IRIS SCS 4-1/2 CVD 101301 manufactured by Integra York, Pa Inc..
[41024828]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[41024829]
Dealer initially reports this instrument tip was broken during pediatric surgery. No broken parts inside the patient. On (b)(6) 2015 dealer reports xray taken confirms no parts left in patient.
Patient Sequence No: 1, Text Type: D, B5
[43729972]
On (b)(6) 2016 integra investigation completed. Failure analysis, device history evaluation failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none engineering change order/manufacturing change order history: none corrective action preventive action history: none health hazard evaluation history: none root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[60927417]
On 11/8/2016 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis: scissor returned in used condition, not showing any unusual markings. While performing the visual inspection of the scissors, it is noticed that one of the tips is broken. The complaint is confirmed. Device history evaluation: dhr review. Nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00041 |
| MDR Report Key | 5520387 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-09 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-03-23 |
| 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 | CARB-EDGE IRIS SCS 4-1/2 CVD |
| Generic Name | N/A |
| Product Code | HNF |
| Date Received | 2016-03-23 |
| Catalog Number | 101301 |
| Lot Number | 8859113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |
| Brand Name | CARB-EDGE IRIS SCS 4-1/2 CVD |
| Generic Name | N/A |
| Product Code | HNF |
| Date Received | 2016-03-23 |
| Returned To Mfg | 2016-10-28 |
| Catalog Number | 101301 |
| Lot Number | 8859113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-03-23 |