MAUDE Adverse Event Report: AESCULAP, INC KERRISON RONGUER; AESCULAP KERRISON RONGUER

Model Number FK927B

Device Problem Component Missing (2306)

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

Event Date 07/26/2017

Event Type  malfunction  

Event Description

It was noticed that the head of the screw on the ejector tip kerrison was missing.The nurse was unable to find the screw so flat plate x-ray done to rule out retained foreign object (rfo).Xray confirmed no rfo.

• Brand Name: KERRISON RONGUER
• Type of Device: AESCULAP KERRISON RONGUER
• Manufacturer (Section D): AESCULAP, INC; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6864483
• MDR Text Key: 86119572
• Report Number: 6864483
• Device Sequence Number: 1
• Product Code: KBB
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FK927B
• Device Catalogue Number: 3119
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2017
• 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: 62 YR