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 2019-11-20 for CASPAR RONGEURUP-BITESERR 3MM160MM FF543R manufactured by Aesculap Ag.
[179251246]
Manufacturing site evaluation: product has been received for investigation, fell off mouth part sent in together with instrument. The instrument is in a decontaminated condition. According to the available information, there were no negative consequences for the patient. The instruments upper mouth part is broken investigation: vigilance investigator carried out the pictorial documentation visually and microscopically. During investigation the breakage surfaces of the broken mouth part and the remained part on the instrument have been analysed. The analysis of the fracture pattern illustrated a forced fracture due to overload. No pores, inclusions or foreign bodies could be found on the point of rupture. Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage. Rationale: according to the investigation results a material defect and production error can be excluded. Based on the analysis of the breakage surface, most probably the breakage was caused by an overload situation during the surgery. Corrective action: corrective action and preventive action is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[179251247]
It was reported that there was an issue with rongeur caspar. It was reported that one of the grasping parts broke off during operation. The instrument was not being used on hard tissue or bone. The broken part was immediately removed without problems. There was no patient harm. An additional medical intervention was not necessary. There was no surgery delay. Additional information was not provided nor available. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00795 |
| MDR Report Key | 9348937 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2019-11-20 |
| 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 RONGEURUP-BITESERR 3MM160MM |
| Generic Name | BONE PUNCHES, RONGEURS |
| Product Code | HTX |
| Date Received | 2019-11-20 |
| Returned To Mfg | 2019-10-31 |
| Model Number | FF543R |
| Catalog Number | FF543R |
| 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 | 2019-11-20 |