MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NON OPTICAL FLEXIBLE AND SEMIRIGID BIOPSY FORCEPS; BIOPSY FORCEPS, 28 CM

Model Number	27071ZJ
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the forceps broke while performing a stone rem.After the breakage the forceps could no longer be closed and therefore could not be removed from the bladder.The cystoscopy had to be converted to a laparotomy to remove the broken forceps from the bladder.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation:the product was returned on august 15,2024.The investigation of the product was completed on september 27,2024.The returned article and the information provided by the customer were examined.The customer states that the forceps broke while trying to remove a bladder stone.He was unable to close the forceps to remove it from the bladder.Upon examination of the article, it was confirmed that the joints at the distal end of the instrument are defective.The article in question is intended for sample excisions and is therefore not suitable for removing stones.The distal end features a sharp curette designed for tissue sampling and diagnostic purposes.Attempting to use this instrument to grasp harder objects than soft tissue will create excessive force on the jaws, draw rod and joints, which can cause the instrument to break.This defect is therefore due to incorrect use by the user.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: NON OPTICAL FLEXIBLE AND SEMIRIGID BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS, 28 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19962753
• Report Number: 9610617-2024-00287
• Device Sequence Number: 15636351
• Product Code: OCZ
• UDI-Device Identifier: 04048551079133
• UDI-Public: 04048551079133
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27071ZJ
• Device Catalogue Number: 27071ZJ
• Device Lot Number: RM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 09/27/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/06/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown