MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2020-02-27 for LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM NL6146 manufactured by Carefusion, Inc.
[184642407]
(b)(4). On 19feb2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent. Customer submitted emdr and provided uf/importer report # 2301650000-2020-8001.
Patient Sequence No: 1, Text Type: N, H10
[184642408]
Via email: the jaws of the narrow pituitary, out of the neuro ronguer set 002, broke while operating inside the disc space. Per the scrub tech, the instrument was not damaged or bent prior to doctor using it. Surgery was prolonged while trying to retrieve the broken piece of the instrument. The broken piece was successfully removed from the patient. What was the original intended procedure: microdiskectomy percutaneous, minimally invasive laminectomy. Additional procedure information: minimally invasive left l5-s1 hemi laminectomy with foraminotomy and microdiskectomy w/fluoro and nuvasive neuro monitoring (b)(6) 2020. The patient is a (b)(6) year old white male. 25feb2020 additional information: was there a medical procedure performed to verify if the instrument was in the patient? S body, such as an x-ray? No xray was necessary. The broken piece was successfully removed from the patient. What was the patient? S outcome? No harm. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2020-00009 |
| MDR Report Key | 9764341 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM |
| Generic Name | RONGEUR, MANUAL |
| Product Code | HAE |
| Date Received | 2020-02-27 |
| Catalog Number | NL6146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |