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

Model Number	27023FM
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittlestrasse 8; tuttlingen 78503 ; GM 78503
• MDR Report Key: 6989191
• Report Number: 9610617-2017-00091
• Device Sequence Number: 903213
• Product Code: FGC
• UDI-Device Identifier: 04048551073681
• UDI-Public: 4048551073681
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K945907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 27023FM
• Device Catalogue Number: 27023FM
• Device Lot Number: PT02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 131