MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-16 for METZENBAUM SCISSORS CVD180MM BC606R manufactured by Aesculap Ag.
[133318691]
(b)(4). Additional information / investigation results will be provided in a supplemental report if required. Manufacturing site evaluation: the product was not returned and pictures were not provided. 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 was 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 maintenance or usage related. Rationale: unfortunately, due to the lack of data and without the product we cannot determine the exact cause. According to the quality standard a material defect and production error can be excluded. Due to the statement from quality management, the instrument consists of three individual parts. There is the possibility for a loosened screw. This could have been caused by improper maintenance after reprocessing. Possibly the instrument was dismantled for reprocessing or the screw has loosened for example due to usage. Another cause could be the breakage of the screw connection. This could have been caused by an improper handling due to a mechanical overload situation. If further investigations are required, the product should be provided for examination. According to the ifu, the following points must be observed for safe handling and preparation: prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components; after each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational, and free of damage (e. G. Broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).
Patient Sequence No: 1, Text Type: N, H10
[133318692]
It was reported that there was an intraoperative issue with the metzenbaum scissors. During an unspecified surgery, the scissors came apart inside the patient. It was confirmed that all 3 pieces were retrieved successfully and removed. The details on possible intervention required or possible surgical delay was unknown. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00032 |
| MDR Report Key | 8254321 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-16 |
| Date of Report | 2019-03-11 |
| Date of Event | 2018-12-28 |
| Date Facility Aware | 2019-01-15 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-01-16 |
| 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 | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI MO 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| 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 | METZENBAUM SCISSORS CVD180MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | LRW |
| Date Received | 2019-01-16 |
| Model Number | BC606R |
| Catalog Number | BC606R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-01-16 |