MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-23 for SURGICAL KNIFE HANDLE #7 6-3/8IN SU1407 manufactured by Carefusion.
[20955201]
The knife blade dislodged from the knife handle and lodged in the patient's knee joint during surgery. The number eleven (11) blade was removed with a hemostat. The physician had to alter the incisions during knee arthroscopy to retrieve blade.
Patient Sequence No: 1, Text Type: D, B5
[21235975]
(b)(4). In retrospective review by carefusion representatives, it was determined that this event necessitates submission as an mdr in adherence with 21 code of federal regulation part 803. No instrument was received for evaluation. Since no sample was received, it was not possible to validate the deficiency or determine if further analysis was required. Although a sample was not received, a detailed review of the device history record, complaint history log, and reports of internal non-conformances were conducted. No non-conforming trends or significant reports of failures from this review were identified. A device history review was conducted with no issues noted. Root cause not determined as there was no sample available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2011-00008 |
| MDR Report Key | 2262239 |
| Report Source | 05 |
| Date Received | 2011-09-23 |
| Date of Report | 2009-11-17 |
| Date of Event | 2009-09-17 |
| Date Mfgr Received | 2009-11-17 |
| Date Added to Maude | 2011-09-28 |
| 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 Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL KNIFE HANDLE #7 6-3/8IN |
| Generic Name | HANDLE, SCALPEL |
| Product Code | EMF |
| Date Received | 2011-09-23 |
| Model Number | SU1407 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-23 |