MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG KERRISON RONGEUR

Model Number N1950

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

Instrument, kerrison ronguer, passed from surgeon to pa student, pa student advised how to operate instrument.Upon utilizing instrument, tip of instrument was found to have broken off.Broken piece was retrieved from surgical field.Instrument removed from field and/or and brought to reprocessing.

• Brand Name: KERRISON RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 11541852
• MDR Text Key: 241440916
• Report Number: 11541852
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N1950
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2021
• Date Report to Manufacturer: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA