MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-01-06 for SWITCH-BLADE 89-5103 manufactured by Carefusion.
[1412202]
The tip fell off in a pt. Additionally, account stated the retractor was being utilized during a laparoscopic cholecystectomy procedure. The surgeon used the instrument with scissors attached to cut cystic duct and proceeded to remove the product from the trocar. The surgeon removed the instrument from the trocar after pulling on it three times. The scissors were missing from the instrument, but located in the pt's abdomen and removed with forceps. The scissors were re-attached to the instrument and used to make other cuts in order to complete the case. The case was completed without incident and the scissors were discarded.
Patient Sequence No: 1, Text Type: D, B5
[8512609]
A sample was received for eval from customer; however, it only consisted of the handle to the device. The accompanying scissor tip was not provided by the customer for eval. An eval of the device handle that was provided indicated damage to the rim and to a portion of the distal end threads. The manufacturing documentation for the handle lot number was thoroughly reviewed and no discrepancies were noted the would have caused the reported incident. Additionally, an empty labeled pouch was received from the customer. The empty labeled pouch was inspected and was different from the device packaging used by the original manufacturer. The labeled pouch appeared to be from re-processing center outside of the original manufacturer. Given the intended use of this product (single-use as stated on the device labeling by the original manufacturer), the sample appeared to have been re-processed in an off-label fashion. This was confirmed by this customer during a f/u call. We have directly communicated the intended use of this product with this customer in an effort to prevent any future product performance issues that may be associated with off-label use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2010-00007 |
| MDR Report Key | 1582489 |
| Report Source | 05 |
| Date Received | 2010-01-06 |
| Date of Report | 2010-01-05 |
| Date of Event | 2009-11-16 |
| Date Mfgr Received | 2009-12-07 |
| Date Added to Maude | 2010-08-25 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW 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 HANDLE |
| Product Code | EMF |
| Date Received | 2010-01-06 |
| Model Number | 89-5103 |
| Catalog Number | 89-5103 |
| Lot Number | NO LOT GIVEN |
| 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 | MCGRAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-01-06 |