MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM RONGEUR, MANUAL

Catalog Number NL6146

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

• Brand Name: LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 9764341
• MDR Text Key: 184642407
• Report Number: 1423507-2020-00009
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: NL6146
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/27/2020 Patient Sequence Number: 1