MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-28 for NOIR IRIS WVCT SCISSORS CVD.S/S 110MM BC211WB manufactured by Aesculap Ag.
[140173551]
No product at hand. Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible. Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale: according to the quality standard a material defect and production error can be excluded. Without the product we cannot determine the exact cause. There is the possibility for a usage error due to improper handling or mechanical overload situation. If further investigations are required, the product should be provided for examination. No capa necessary. If additional is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[140173552]
It was reported that during a surgical breast procedure the scissor tips broke while cutting breast tissue. A pair of back up scissors were retrieved to complete the procedure. This incident did not cause or contribute to a serious injury, death or a delay in surgery. No other information has been provided. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00199 |
| MDR Report Key | 8460189 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-01 |
| Date Facility Aware | 2019-03-18 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOIR IRIS WVCT SCISSORS CVD.S/S 110MM |
| Generic Name | NOIR IRIS WVCT SCISSORS CVD.S/S 110MM |
| Product Code | LRW |
| Date Received | 2019-03-28 |
| Model Number | BC211WB |
| Catalog Number | BC211WB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |