MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-16 for SWITCH-BLADE 89-5103 manufactured by Carefusion.
[20935032]
Surgeon was using product, after 6 hours the coating around the edge of the blade began peeling and fell into the pt. Additionally, account stated the case was delayed, while the surgeon used a grasper to locate and remove all the material from the pt.
Patient Sequence No: 1, Text Type: D, B5
[21198918]
Visual examination of the device received confirmed that the insulation was compromised near the scissor blades. It was also noted that the insulation was completely removed from approx 5mm from the proximal end of the clevis, and damaged/peeled back, burnt or missing to about 12mm from the proximal end. The device's appearance resembled what one would expect if the device was used and reprocessed more than once. It was also noted that the mating part (the switch-blade handle) to this device was not returned with the device for eval. Add'l info has not been provided. A review of the device history record for this device and lot number determined that the material used during the mfg met current specifications. Our complaint records for this catalog and lot number does not indicate a pattern of insulation failures of this nature. Since the root cause for the concern is not related to the mfg, materials, or design of the instrument, a corrective and preventive action will not be initiated. Our records have been updated, which will provide for identification of trends, should similar reports be received in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2010-00010 |
| MDR Report Key | 1668527 |
| Report Source | 05 |
| Date Received | 2010-04-16 |
| Date of Report | 2010-04-16 |
| Date of Event | 2010-03-08 |
| Date Mfgr Received | 2010-03-18 |
| Device Manufacturer Date | 2008-03-21 |
| Date Added to Maude | 2010-11-03 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWITCH-BLADE |
| Generic Name | SWITCH-BLADE |
| Product Code | EMF |
| Date Received | 2010-04-16 |
| Model Number | 89-5103 |
| Catalog Number | 89-5103 |
| Lot Number | 806989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-16 |