MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-15 for TC TENOTOMY SCISSDELCVD1/SERR130MM DO250R manufactured by Aesculap Ag.
[102582680]
(b)(4). Manufacturing site evaluation: the tip of the scissors are broken. Pictorial documentation was carried out with a digital microscope. Hardness measurement was carried out with hardness tester. The device history files have been checked and were found to be according to the specifications. Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage. This kind of instrument is designated for delicate use only. It is liable that a mechanical overload situation led to the breakage. The visual investigation and the hardness test indicated that the quality requirements are in the specified tolerance range. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[102582681]
Country of complaint: usa. Customer states that during intra-operative surgery the tip of scissors broke off. No surgical delay and no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00100 |
| MDR Report Key | 7343488 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-15 |
| Date of Event | 2016-08-29 |
| Date Facility Aware | 2018-02-27 |
| Date Mfgr Received | 2016-08-31 |
| Device Manufacturer Date | 2016-04-19 |
| Date Added to Maude | 2018-03-15 |
| 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 |
| 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 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 TENOTOMY SCISSDELCVD1/SERR130MM |
| Generic Name | DENTAL SCISSORS |
| Product Code | EGN |
| Date Received | 2018-03-15 |
| Returned To Mfg | 2016-11-03 |
| Model Number | DO250R |
| Catalog Number | DO250R |
| Lot Number | 4507434213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 23 MO |
| 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 | 1. Other | 2018-03-15 |