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 2019-10-02 for CASPAR RONGEURSTRSERR 2X12MM160MM FF532R manufactured by Aesculap Ag.
[176064120]
Investigation results: the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq. -nr. 2000024840) and the digital-camera "panasonic dmc tz8". The instrument arrived in a clean status with visible damage but without the broken off part. We made a visual inspection of the instrument. Here we found a deformed jaw hinge. Additionally we made an optical inspection of the fracture surface. No abnormalities were detected. The device quality and manufacturing history records have been checked for the lot number (4510207037) and found to be according to the specification valid at the time of production. No similar incidents have been filed with products from this batch. The root cause of the problem is most probably usage related. According to the quality standard and dhr files a material defect and production error can be excluded. No pores or foreign bodies could be found on the point of rupture. Investigations lead to the assumption that the breakage was caused by an improper handling due to a mechanical overload situation. There is the possibility of torsion or high leverage with the instrument. The deformed jaw hinge is an additional sign for a mechanical overload situation.
Patient Sequence No: 1, Text Type: N, H10
[176064121]
It was reported that there was an issue with the product caspar rongeurstrserr 2x12mm160mm. The doctor claims that the jaw was broken during the operation. The broken part could be removed from the operation area. There was no patient harm. This malfunction prolonged the surgery for approx. 30 minutes. The malfunction is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00688 |
| MDR Report Key | 9146116 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-02 |
| Date of Report | 2019-10-02 |
| Date Mfgr Received | 2019-09-03 |
| Device Manufacturer Date | 2019-01-14 |
| Date Added to Maude | 2019-10-02 |
| 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 KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | CASPAR RONGEURSTRSERR 2X12MM160MM |
| Generic Name | BONE PUNCHES, RONGEURS |
| Product Code | HTX |
| Date Received | 2019-10-02 |
| Returned To Mfg | 2019-09-12 |
| Model Number | FF532R |
| Catalog Number | FF532R |
| Lot Number | 4510207037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-10-02 |