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 2019-05-17 for KELLY FORCEPS DEL CVD 140MM BH135R manufactured by Aesculap Ag.
[145658752]
(b)(4). Manufacturing site evaluation: the instruments arrived in a decontaminated condition and they are available for investigation. The instruments had visible damage and the broken off parts. Investigation: performed visually and microscopically. Here we made an optical inspection of the fracture surface, and found discoloration and cracks. We also discovered an intercrystalline fracture. A visual inspection of the broken off parts showed visibly damaged tooth tips. Additionally, inspection of the fracture surface showed discoloration, cracks, and unknown residues; and an intercrystalling fracture. Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production. One similar incident has been filed with a product from the batch. Conclusion and root cause: the root cause of the problem is most probably manufacturing, design and reprocessing related. Rationale: investigations led to the assumption that the breakage was caused by stress-corrosion cracking. We assume pre-damage due to a manufacturing error by unfavourable production-related circumstances, such as sharp-edged milling transitions, as well as critical material tensile stress conditions due to straightening work. We also assume that the discolorations are signs of an old crack. There is the possibility that the visibly damaged tooth tips were caused due to a manufacturing error by straightening work. Due to the existing pre-damage or weak point, the reprocessing was fracture-triggering. We assume that the cracks are ferrite rusticates/ferrite microstructures. The microstructure, chemical composition, hardness and material toughness comply with the specifications. The material as well as the heat treatment can be excluded as cause of damage/breakage. Various tests are carried out to derive measures to prevent and or minimize material breakage. In additional to the boiling stress test, a test plan was also prepared.
Patient Sequence No: 1, Text Type: N, H10
[145658753]
It was reported that there was an issue with the instrument intraoperatively. During an aortic valve replacement surgery, the clamp fractured at the jaw while pulling a suture. There was a surgical delay of about 20 minutes while other instruments were provided. There was no patient harm. Additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00345 |
| MDR Report Key | 8621593 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-02-22 |
| Date Facility Aware | 2019-05-14 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2018-04-04 |
| Date Added to Maude | 2019-05-17 |
| 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 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 | KELLY FORCEPS DEL CVD 140MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | HRQ |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-04-05 |
| Model Number | BH135R |
| Catalog Number | BH135R |
| Lot Number | 4509508222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 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 | 2019-05-17 |