MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-03 for TROCAR HANDLE 25-472-05-07 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[122533505]
(b)(4). Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00236.
Patient Sequence No: 1, Text Type: N, H10
[122533506]
It was reported a patient was burned while using a twist drill and trocar. The twist drill was being used at 20,000 rmps. It is stated in ifu (b)(4) "twist drills are not designed to be used at speeds in excess of 5000 rpm. "
Patient Sequence No: 1, Text Type: D, B5
[132430902]
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation. The complaint percentage falls within the design risk limits adhered to at klm. The review of the device history records was not possible due to no lot number being identified. The ifu indicates that drills are not to be used with than 5000 rmp. The provided information reveal that the root cause was an incorrect use by the customer. If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610905-2018-00237 |
| MDR Report Key | 7931134 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-09-05 |
| Date Facility Aware | 2018-12-18 |
| Report Date | 2018-09-05 |
| Date Reported to Mfgr | 2018-09-05 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2018-10-03 |
| 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. JENNIFER DAMATO |
| Manufacturer Street | P.O. BOX 16369 |
| Manufacturer City | JACKSONVILLE FL 32245 |
| Manufacturer Country | US |
| Manufacturer Postal | 32245 |
| Manufacturer Phone | 9046417746 |
| Manufacturer G1 | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
| Manufacturer Street | KOLBINGER STRASSE 10 |
| Manufacturer City | MUEHLHEIM/DONAU, 78570 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROCAR HANDLE |
| Generic Name | TROCAR HANDLE |
| Product Code | LRC |
| Date Received | 2018-10-03 |
| Model Number | 25-472-05-07 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
| Manufacturer Address | KOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-03 |