MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-19 for LOVE-GRUENWALD PITUITARY FCPS, NL6146 manufactured by Carefusion.
[16037796]
Customer stated that the lower portion of the jaw snapped off while in use. Additionally, the account stated, the instrument was being utilized during a laparoscopic discectomy when the lower portion of the jaw broke off inside of the pt. The case was delayed while the surgeon looked for the broken piece on x-ray. The x-ray revealed the missing piece was in the pt's disk space. The surgeon removed the piece and finished the case without further incident. The case was on (b)(6) 2009, the instrument and broken jaw was sent to risk management and not reported to (b)(6) until (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[16097791]
The actual device involved in the incident was returned for eval. However, the complete instrument was not received, (the broken piece was not received); the missing piece is crucial for a complete and accurate analysis of the concern. A review of our device history report and complaint history trending has been initiated. Although, the broken piece was not received, an investigation of the concern was possible. The top half of the cutter was bent in a manner other than its initial design. Eval of the instrument indicated that the instrument's jaw was bent. This product is not designed to be flexible or malleable. The device history record and trends have been reviewed. There are no records of similar or related reports. Since the root cause is not associated with the design, manufacturing, materials, or craftsmanship of these instruments, a corrective action will not be initiated. As a courtesy, a copy of our directions for use was sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2010-00003 |
| MDR Report Key | 1702504 |
| Report Source | 05 |
| Date Received | 2010-05-19 |
| Date of Report | 2010-05-18 |
| Date of Event | 2009-11-19 |
| Date Mfgr Received | 2010-04-19 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2011-04-28 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD. |
| 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 | LOVE-GRUENWALD PITUITARY FCPS, |
| Generic Name | FORCEP |
| Product Code | EMH |
| Date Received | 2010-05-19 |
| Model Number | NL6146 |
| Catalog Number | NL6146 |
| 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 | 2010-05-19 |