MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY FORCEPS; FLEXIBLE ENDOSCOPY BIOPSY FORCEPS

Model Number	28160ZJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the date of this report the affected device was requested for further investigation, but not returned yet.
Event or Problem Description
It was reported that there was an issue with the product 28160zj - biopsy forceps, 1 mm, 30 cm.The device broke during surgery.According to the complaint description, one of the jaws of the biopsy forceps broke during ventriculostomy in the context of the management of a colloid cyst responsible for hydrocephalus.Broken jaw piece not found.At this stage, no complications for the patient.No clinical consequences.Internal reference number: (b)(4).
Event or Problem Description
Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
The affected device was received by the manufacturer october 7, 2022.Based on the initial investigation, the product history did not show any deviation and the product passed the final inspection.Also, by reviewing similar complaints and product history data, there is no indication of systematic error.
Additional Manufacturer Narrative
The compliant product was received on (b)(6) 2022.Visual examination of the affected device revealed that the forceps´ jaw broke off and the axle pin is bent.The broken joint is missing.Due to the deformed and bent axle pin, it is assumed that the device was subjected to high forces.Since this was manufactured in the year 2015 it is very likely that the sharp spoons have worn out due to the many uses over the last 7 years.Therefore, there is a high force effect during surgery while using the device, and causing damage or breakage due to cutting is no longer possible.This could have been prevented by a check before use as well as by a sharpening (maintenance) of the jaw parts.Based on the investigation results, the root cause of the reported issue can be traced back to a usage-related failure/maintenance-related failure.Internal karl storz reference number: (b)(4).

• Brand Name: BIOPSY FORCEPS
• Common Device Name: FLEXIBLE ENDOSCOPY BIOPSY FORCEPS
• 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: pascale bernard ; boulevard de ratalens; saint-jean, 31240 ; FR 31240
• MDR Report Key: 15523593
• Report Number: 9610617-2022-00278
• Device Sequence Number: 14086555
• Product Code: GWG
• UDI-Device Identifier: 04048551097199
• UDI-Public: 4048551097199
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 11/23/2022

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: 28160ZJ
• Device Catalogue Number: 28160ZJ
• Device Lot Number: WU01
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 11/11/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/28/2022; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2015
• 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: Other
• Patient Sex: Unknown