MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-08 for TC MAYO-LEXER SCISSORS CVD 165MM BC284R manufactured by Aesculap Ag.
[132362484]
(b)(4). The instrument is not available for investigation. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. No product available and therefore it is not 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. Due to a lack of data and without the product not determine the exact cause. There is the possibility for a usage error due to a mechanical overload situation. If further investigations are required, the product should be provided for examination.
Patient Sequence No: 1, Text Type: N, H10
[132362565]
During a surgical procedure a piece from the surgical instrument broke off at the outer edge of the chisel. The piece measures about 1mm long and about 0. 5mm wide. At the time of the surgery, particles fell in the patient's scar. Medical device fragments remained in the patient. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00006 |
| MDR Report Key | 8226410 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-08 |
| Date of Report | 2018-01-08 |
| Date of Event | 2018-11-30 |
| Date Facility Aware | 2018-12-21 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2019-01-08 |
| 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 | TC MAYO-LEXER SCISSORS CVD 165MM |
| Generic Name | DUROTIP SCISSORS |
| Product Code | LRW |
| Date Received | 2019-01-08 |
| Model Number | BC284R |
| Catalog Number | BC284R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2019-01-08 |