MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for RECAMIER UTER.CURETTE SH/RIG.#2 10.5MM ER222R manufactured by Aesculap Ag.
[100777132]
(b)(4). Manufacturing site evaluation: the working end is broken off. The surface is not longer in the delivered condition. The investigation was carried out visually. The taped surface and also the foreign labeling are indicators of a third party maintenance, presumably carried out in april 2011. The analysis of the fracture pattern illustrated a forced fracture due to overload. A review of the device and manufacturing history records was not possible because the lot number is unknown. 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. Due to a long term-use since 2011 it is excluded a design or production related error. Since this is not a fatigue-fracture, a breakage due to an overload situation is obvious. Based on the third party maintenance it can no longer guaranty a function according to oem specification. The current failure rate is within the risk analysis and therefore acceptable. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[100777133]
(b)(6). In the context of a therapeutic curettage the curette broken out. The loop of the curettage remained in uterus. Removal not possible. Decision to vaginal hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00098 |
| MDR Report Key | 7287216 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-08-31 |
| Date Facility Aware | 2017-10-04 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2018-02-21 |
| 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 | 0 |
| Brand Name | RECAMIER UTER.CURETTE SH/RIG.#2 10.5MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | HCY |
| Date Received | 2018-02-21 |
| Returned To Mfg | 2018-10-13 |
| Model Number | ER222R |
| Catalog Number | ER222R |
| 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 | 1. Other | 2018-02-21 |