MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER; RONGEUR, MANUAL

Model Number NL3785-164

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 04/12/2018

Event Type  malfunction  

Event Description

Number 1 kerrison instrument used during posterior cervical instrumentation.Tip of kerrison noted to have broken off during procedure.Radiographic confirmation obtained that tip of instrument was not retained in patient.Suction filter was radiographed and tip found to be seated in filter of the suction machine.Cpd (central processing department) manager notified.Broken instrument isolated w/ suction filter and given to central processing department who dismantled suction filter and sifted the piece out.

• Brand Name: V. MUELLER
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 7475432
• MDR Text Key: 106988648
• Report Number: 7475432
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018,04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NL3785-164
• Device Catalogue Number: NL3785-164
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 107