MAUDE Adverse Event Report: CAREFUSION 2200, INC DAWSON-YUHL-LEKSELL RONGEUR FORCEPS; ROUNGEUR

Model Number NL7100-040

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Leksell rongeur separated into two pieces while in use during procedure.One small metal piece was determined to be missing, but surgical tech was unsure whether the instrument was broken prior to the case started or if it actually broke while in use during the case.Surgical field searched, surrounding bed/floor/table searched, x-ray taken without locating missing metal piece.Radiologist confirmed no retained foreign objects present in wound.

• Brand Name: DAWSON-YUHL-LEKSELL RONGEUR FORCEPS
• Type of Device: ROUNGEUR
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 13654269
• MDR Text Key: 286464587
• Report Number: 13654269
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL7100-040
• Device Catalogue Number: NL7100-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female
• Patient Weight: 79 KG