MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-05-13 for CAUTERY FORCEPS 100-004D 110-004D manufactured by Starion Instruments.
[2002831]
This was originally reported as the ends melted. During the investigation it was determined that the boot was split. No pt info was provided.
Patient Sequence No: 1, Text Type: D, B5
[9055580]
One cautery forceps was returned, decontaminated and investigated. A visual inspection found a distal tear located on the toothed side of the boot. This boot was split, not "melted" and no material was missing. A closer inspection of the boot tear revealed that the thickness of the tip boot appeared thin. If the device is activated w/o tissue being present with the jaws, the tip boot wall is pre-stressed by over stretching, causing the boot to split. The combination of the thinner boot and an over stressed boot may have helped develop the boot split when the device was activated. A review of the same possible boot configuration found that this is an isolated incident. The returned device was electrically inspected and meets standards. A review of the device history record found no issues. Complaints of the devices built with the same boot lot number were reviewed for any similar instances to determine the frequency of the issue. This situation will be monitored.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954339-2011-00013 |
| MDR Report Key | 2102978 |
| Report Source | 08 |
| Date Received | 2011-05-13 |
| Date of Report | 2011-05-12 |
| Date Added to Maude | 2011-07-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEAN CIPORKIN |
| Manufacturer Street | 1227 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085225200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAUTERY FORCEPS |
| Generic Name | CAUTERY FORCEPS |
| Product Code | HQR |
| Date Received | 2011-05-13 |
| Model Number | 100-004D |
| Catalog Number | 110-004D |
| Lot Number | 006003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STARION INSTRUMENTS |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-13 |