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 2019-09-19 for HOUSE CURETTEDBL-ENDANG-CUPS1.5&1.8MM OG185R manufactured by Aesculap Ag.
[159176497]
Investigation results: the instrument arrived in a clean status with visible damage and the broken off part. The investigation was carried out visually and microscopically. We made a visual inspection of the instrument and of the fracture surface. No abnomalities were detected. Additionally we made an optical inspection ot the broken off part and of the fracture surface. We discovered unknown impurity but no abnomalities. The device quality and manufacturing history records have been checked for the lot number (52286844) 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 device history record files a material defect and production error can be excluded. No pores or inclusions could be found on the point of rupture. Investigations lead to the assumption that the breakage was caused by an improper handling. There is the possibility for a mechanical overload by torsion or high leverage with the instrument.
Patient Sequence No: 1, Text Type: N, H10
[159176498]
It was reported that there was an issue with product house curettedbl-endang-cups 1. 5 & 1. 8mm. Item was being used in surgery and snapped off during normal use. Patient harm is unknown. Information has been requested at the clinic at least three times additional information was not available. The malfunction is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00647 |
| MDR Report Key | 9087062 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-19 |
| Date of Report | 2019-09-18 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2019-09-19 |
| 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 | HOUSE CURETTEDBL-ENDANG-CUPS1.5&1.8MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FZS |
| Date Received | 2019-09-19 |
| Returned To Mfg | 2019-09-11 |
| Model Number | OG185R |
| Catalog Number | OG185R |
| Lot Number | 52286844 |
| 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 | 2019-09-19 |