MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for SENSATION MICRSCIS S/S BAY CVD 120/245MM FM125R manufactured by Aesculap Ag.
[115109215]
(b)(4). Manufacturing site evaluation: according to the available information, there were no negative consequences for the patient. The pair of scissors is broken at the connection screw. Two handle parts and one blade fragments are available for investigation. The investigation was carried out visually. The device quality and manufacturing history records have been checked for the available lot number. The device history has been checked and found to be according to specifications valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available as well as a result of the investigation the root cause of the failure is most probably elated to insufficient usage. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[115109216]
Country of complaint: (b)(6). It was reported that the customer complains that in the sterile procesign department the metal part of the scissor broke at the point where the screw is. This is the 2nd time this has happened. No surgical delays and no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00341 |
| MDR Report Key | 7716365 |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-06-15 |
| Date Facility Aware | 2018-07-23 |
| Date Mfgr Received | 2016-06-21 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2018-07-24 |
| 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 | SENSATION MICRSCIS S/S BAY CVD 120/245MM |
| Generic Name | MICRO-NEURO INSTRUMENTS |
| Product Code | GZX |
| Date Received | 2018-07-24 |
| Returned To Mfg | 2018-07-15 |
| Model Number | FM125R |
| Catalog Number | FM125R |
| Lot Number | 52109277 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| 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 | 2018-07-24 |