MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-03 for IRIS SCS 4-1/2 CVD 360101 manufactured by Integra York, Pa Inc..
[37433920]
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
[37433921]
The or was using a pair of scissors on a finger. When finished the doctor noticed a small tip missing from the scissors. They x-rayed the finger and the piece was in the wound. They had to reopen the wound then re suture. On (b)(6) 2016 no further information available.
Patient Sequence No: 1, Text Type: D, B5
[38310411]
On 2/3/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - scissors were returned in used condition, showing a green tape marking. The returned scissor showing wear, staining and a broken tip. Upon visually inspecting the instrument, it is noticed that there is staining at the hinge area; and the tip is broken. It is also noticed that there is black staining where the breakage is. This is the result from detergents used to clean the instrument. The black acid staining can be caused by low ph (less than six) during autoclaving. This can weaken the metal causing breakage. This type of damage is typically the result of improper processing. Condition of the instrument reveals improper care. The complaint report is confirmed; damaged worn. Device history evaluation - dhr review was completed with all history available. Nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: there is no applicable variance authorization / deviation history. 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 | 2523190-2016-00011 |
| MDR Report Key | 5408000 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-19 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2016-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | IRIS SCS 4-1/2 CVD |
| Generic Name | N/A |
| Product Code | HNF |
| Date Received | 2016-02-03 |
| Returned To Mfg | 2016-01-28 |
| Catalog Number | 360101 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2016-02-03 |