MAUDE Adverse Event Report: KARL STORZ GMBH AND CO LARGE STONE GRASPING FORCEPS

Model Number 27290H

Device Problem Material Separation (1562)

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

Event Date 11/11/2014

Event Type  malfunction  

Event Description

Allegedly, doctor was performing a percutaneous nephrolithotomy, when one of the prongs on grasper broke off into pt.The broken grasper was removed from the surgical area and another grasper was used to retrieve the piece in the pt.

Manufacturer Narrative

The instrument was not returned for evaluation.Per the customer, device is approximately 10 years old.The device breakage is consistent with stress overload and wear and long usage.

• Brand Name: LARGE STONE GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ GMBH AND CO; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH AND 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: 4589626
• MDR Text Key: 5338671
• Report Number: 9610617-2015-00017
• Device Sequence Number: 1
• Product Code: FGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27290H
• Device Catalogue Number: 27290H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 97