MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM NL6146 manufactured by Carefusion, Inc.
[135508655]
(b)(4) on (b)(6) 2019, 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.
Patient Sequence No: 1, Text Type: N, H10
[135508656]
It was reported via email: yesterday one of our pituitary? S had a piece of metal come off during a case. The tech saw it and it wasn? T left in the patient, but we had to take it out of service. What was the procedure that was being performed? Cervical disc replacement. Did any part the instrument fall into the patient? S body, and if so, how was it retrieved? Unknown. Was there a medical procedure performed to verify if the instrument was in the patient? S body, such as an x-ray? X-ray down, nothing seen on x-ray. What was the patient? S outcome? Stable, normal outcome. Was the procedure completed as planned? Yes. Can you please send all parts of the instrument for evaluation? Yes, metal piece was found and matched to instrument. Do you have the lot number? J17xsx. Could you please clarify where was the broken piece found? It was found on a sponge by the scrub tech after wiping the instrument after normal use. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2019-00001 |
| MDR Report Key | 8262616 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-01-18 |
| 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 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 | 0 |
| Brand Name | LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM |
| Generic Name | KERRISON RONGEURS |
| Product Code | HAE |
| Date Received | 2019-01-18 |
| Catalog Number | NL6146 |
| Lot Number | J17XSX |
| 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 | 2019-01-18 |