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 2018-09-20 for JAW INS.METZENBAUM SCISSORS 5MM 310MM PO603R manufactured by Aesculap Ag.
[120960830]
(b)(4). The components of the device have been examined digitally and microscopically under a microscope and the tubes was found to be melted and contained black residue. The components of the device have been examined digitally and microscopically under a microscope and the tubes was found to be melted and contained black residue. According to the quality standard a material defect and production error can be excluded. During the investigation, it was lead to believe that the melted outer tube was caused by visible damages, scratches and grooves. It may also be a result of coming into contact with other instruments or improper handling of the device. Additionally the outer tube showed heavy signs wear. Due to the manufacturing date of 01/01/2011, the device may have undergone more 300 cycles of reprocessing. The service life of the device will depend on the individual intraoperative usages and specific reprocessing conditions. Due to the reprocessing procedure, there is a possibility of pre-damage isolation. The root cause of the problem is most likely usage and maintenance related. A batch history review is not possible because the lot number is unknown. These are both related cases: 400401421-9610612-2018-00418, 400401420-9610612-2018-00419.
Patient Sequence No: 1, Text Type: N, H10
[120960831]
During surgery, it was noted that the outer tube of the jaw insert got charred. The surgery was delayed with 20min.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00419 |
| MDR Report Key | 7895784 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-20 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-08-09 |
| Date Facility Aware | 2018-08-31 |
| Date Mfgr Received | 2018-08-27 |
| Date Added to Maude | 2018-09-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP USA |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAW INS.METZENBAUM SCISSORS 5MM 310MM |
| Generic Name | ADTEC MONOPOLAR |
| Product Code | KNF |
| Date Received | 2018-09-20 |
| Returned To Mfg | 2018-08-27 |
| Model Number | PO603R |
| Catalog Number | PO603R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| 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 | 2018-09-20 |