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.
[3101368]
Complaint is reported as: when two "c" size batteries are installed into the handle the battery retainer cap begins to heat. This occurred during post op inspection, after sterilization.
Patient Sequence No: 1, Text Type: D, B5
[10388443]
Product has not yet 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 | 1044475-2012-00167 |
MDR Report Key | 2885823 |
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 |