MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-08 for TC NELSON-METZ SCISSORS DEL CVD 285MM BC281R manufactured by Aesculap Ag.
[144968966]
(b)(4). Preliminary investigation: a visual inspection of the instrument and of the fracture surface. The instrument was sent to the production department for further investigation. The report will be updated when we receive a statement from the production department. Batch history review: the device quality and manufacturing history records will be checked for the lot number 4509144704 from the quality coordinator of the production plant. After review, the report will be updated. No similar incidents have been filed with products from this batch. Conclusion and root cause: the root cause could be manufacturing related. The report will be updated when we receive a statement from the production department. Rationale: due to the circumstance that the product has been sent to the manufacturer for an analysis this is a preliminary report and it will be updated when we receive a statement from the manufacturer. Investigations lead to the assumption that the scissor part was damaged before soldering the carbide due to the signs of soldering deposits. There is also the possibility that the scissor part was not completely pronounced or was damaged during production. We are currently unable to determine any fracture surface. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[144968967]
It was reported a missing piece was seen on scissor blade. The reporter indicated that during the packing process it was noticed that a piece of the blade broke off. It is unknown where the broken part is located. Per the reporter, the broken piece was so small that it was noticed only during the packaging process and unfortunately not earlier and it is possible that this could have happened weeks ago. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00302 |
| MDR Report Key | 8592734 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-22 |
| Date Facility Aware | 2019-05-10 |
| Date Mfgr Received | 2019-05-10 |
| Device Manufacturer Date | 2017-12-08 |
| Date Added to Maude | 2019-05-08 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| 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 NELSON-METZ SCISSORS DEL CVD 285MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | LRW |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-04-17 |
| Model Number | BC281R |
| Catalog Number | BC281R |
| Lot Number | 4509144704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-08 |