MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP KERRISON RONGEUR; KERRISON RONGEUR SURGICAL INSTRUMENT

Catalog Number FK901B

Device Problem Bent (1059)

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

Event Date 07/29/2015

Event Type  malfunction  

Event Description

There have been numerous issues with the aesculap fk901b 2mm kerrison rongeurs bending at the shaft of the instrument near the footplate (distal end of instrument ).This is the actual working cutting end of the device when used during laminectomy cases.We have submitted instruments to aesculap in the past for quality assurance (qa) evaluations and on 2 occasions received replies back indicating there is no defect in instrument, but damage is due to user error.This has been an ongoing issue with the devices bending.Today, our central sterile manager provided a total of 6 rongeurs to aesculap for qa evaluation.The aesculap representative agreed that this is not due to user error and that there appears to be an issue with the rongeurs themselves.We do have 4 replacements provided by aesculap to keep our sets in operation.Our central sterile manager will report back once qa report is received.

• Brand Name: AESCULAP KERRISON RONGEUR
• Type of Device: KERRISON RONGEUR SURGICAL INSTRUMENT
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 5034415
• MDR Text Key: 24219555
• Report Number: 5034415
• Device Sequence Number: 1
• Product Code: HTX
• 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
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FK901B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1