MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-22 for ELECTRO SURGICAL INSTRUMENT COMPANY 08-0070 manufactured by Electro Surgical Instrument Company.
[3159574]
Pt was in surgery for abdominoplasty and mastoplasty. Case began at 9:30 a. M. When relieving scrub nurse began approx 12:00 noon, he/she asked the initial scrub nurse where blisters on the pt's left breast came from. Initial report further stated that the pt was subject to blistering on the lateral aspect of the left breast, and that the fiberoptic refractor may have been placed on the pt during the procedure. Instrumentation included a bfw xi 300 light source, and esi 01-0350 fiberoptic cable connected to an esi 08-0070 deep pelvic retractor. Initial reporter also stated that the devices did not malfunction or become disconnected during the procedure. No further details were given.
Patient Sequence No: 1, Text Type: D, B5
[10447529]
The fiberoptic retractor and cable were returned to esi on (b)(4) 2013 for inspection eval and repair. Fiberoptic cable 01-350 was found to be in new condition with very little signs of wear. The 08-0070 deep pelvic retractor was received well used, and in need of some maintenance. The fiberoptic light carrier had some contamination on both the distal and proximal ends as a result of age, use and continued sterilization. Light transmission through the retractor, although diminished was approx 80 percent capacity. Our records and the lack of serial numbers on this instrument indicate that it has not been returned to esi for maintenance since new. The user facility has many of these retractors and is aware of the warnings regarding the use of xenon light sources that are labeled with each shipment as part of esi care and cleaning. This info is also available via our website. Initial reporter verified that the care and cleaning as well as the subsequent warning is on file at the facility. We expect to replace the fiberoptic light carrier on the 08-0070 retractor, and refurbish the retractor to new condition as well as assign a serial number with current instrument marking procedures and history documentation. Both the 08-0070 retractor and 01-0350 cable will then be returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1315756-2013-00001 |
| MDR Report Key | 2931601 |
| Report Source | 05,06 |
| Date Received | 2013-01-22 |
| Date of Report | 2013-01-18 |
| Date of Event | 2013-01-02 |
| Date Mfgr Received | 2013-01-03 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2013-03-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 37 CENTENNIAL ST. |
| Manufacturer City | ROCHESTER NY 14611 |
| Manufacturer Country | US |
| Manufacturer Postal | 14611 |
| Manufacturer Phone | 5852351430 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRO SURGICAL INSTRUMENT COMPANY |
| Generic Name | FIBEROPTIC RETRACTOR |
| Product Code | FDG |
| Date Received | 2013-01-22 |
| Returned To Mfg | 2013-01-07 |
| Model Number | 08-0070 |
| Catalog Number | 08-0070 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELECTRO SURGICAL INSTRUMENT COMPANY |
| Manufacturer Address | 37 CENTENNIAL ST. ROCHESTER NY 14611 US 14611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-22 |