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

Model Number 27023FM

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

The grasping forceps were not returned to karl storz for evaluation.The hospital sent the forceps to ims a third party repair facility.Although the product still carries karl storz brand name, we cannot be certain whether that was still the original ks product.

Event Description

Allegedly, during a eswl uereteral stone and cystoscopy with stent removal procedure, doctor noted that one of the jaws on grasping forceps broke off into patient's bladder.Doctor located broken piece and attempted to retrieve it, but he was unable to do so.He believes that patient should pass it on his own, since it was smaller than the stones that they were removing.Procedure was completed with no injury to the patient.

• Brand Name: SEMI- RIGID GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittlestrasse 8; tuttlingen 78503 ; GM 78503
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen, 78503 ; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6989191
• MDR Text Key: 91197125
• Report Number: 9610617-2017-00091
• Device Sequence Number: 1
• Product Code: FGC
• UDI-Device Identifier: 04048551073681
• UDI-Public: 4048551073681
• 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 faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 27023FM
• Device Catalogue Number: 27023FM
• Device Lot Number: PT02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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: 64 YR
• Patient Weight: 131