MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for 12' DISP. BIPOLAR FORCEPS CORD (10/BX) 394236 manufactured by Teleflex Medical.
[66333630]
(b)(4). The device history review could not be conducted since the lot number was not provided. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[66333631]
During a carpal tunnel repair the bipolar forceps cord showed sparks between the forcep and the plug into the cord. It burned the end of the cord and the end for the forcep by the post. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[68127032]
(b)(4). Dhr review could not be conducted since the lot number was not provided. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. At this time due the sample is not available is not possible to determine the source of the defect reported. Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause. If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[68127033]
During a carpal tunnel repair the bipolar forceps cord showed sparks between the forcep and the plug into the cord. It burned the end of the cord and the end for the forcep by the post. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00054 |
| MDR Report Key | 6286115 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2017-01-30 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 12' DISP. BIPOLAR FORCEPS CORD (10/BX) |
| Generic Name | ELECTROSURGICAL,CUTTING&COAGULATION |
| Product Code | HAM |
| Date Received | 2017-01-30 |
| Catalog Number | 394236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-30 |