MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG SEMI-RIGID GRASPING FORCEPS

Model Number 27023FM

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Allegedly, during ureteroscopy procedure the forceps broke.The doctor removed the forceps after which a small metal piece from the forceps was seen in the ureter and it was flushed out.There was no injury to the patient.

Manufacturer Narrative

We evaluated the forceps and found that the linkage that attaches to hinge is missing.Damage is most likely due to stress overload.

• Brand Name: SEMI-RIGID GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4892566
• MDR Text Key: 6540929
• Report Number: 9610617-2015-00046
• Device Sequence Number: 1
• Product Code: FGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27023FM
• Device Catalogue Number: SAME
• Device Lot Number: PU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR