MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM; RONGEUR, MANUAL

Model Number NL6146

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/27/2020

Event Type  malfunction  

Event Description

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 dr.Using it.Surgery was prolonged while trying to retrieve the broken piece of the instrument.The broken piece was successfully removed from the patient.

• Brand Name: V. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CAREFUSION 2200, INC; 5 sunnen dr; saint louis MO 63143
• MDR Report Key: 9699244
• MDR Text Key: 178786221
• Report Number: 9699244
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL6146
• Device Catalogue Number: NL6146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16060 DA