MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-12-19 for RUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM 004411100 manufactured by Teleflex.
[3100954]
Complaint is reported as: when two "c" size batteries are installed into the handle the battery retainer cap begins to heat. This occured during post inspection, after sterilization.
Patient Sequence No: 1, Text Type: D, B5
[10363636]
Product has not yet been received by manufacturer, therefore, investigation report is incomplete at this time. A follow-up report will be submitted when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00168 |
| MDR Report Key | 2885819 |
| Report Source | 06,07 |
| Date Received | 2012-12-19 |
| Date of Report | 2012-12-07 |
| Date Mfgr Received | 2012-12-07 |
| Date Added to Maude | 2013-03-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM |
| Generic Name | GREENSPEC FIBEROPTIC HANDLE |
| Product Code | EQN |
| Date Received | 2012-12-19 |
| Catalog Number | 004411100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-19 |