MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY FORCEPS, FLEXIBLE, 1 MM

Model Number	11003MA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported; while attempting to perform a tracheobronchial mucosal biopsy, the forceps lost its movement, making its use impossible.The procedure was canceled.No negative impact in state of health reported.Due to the prolongation of the procedure longer than 60 minutes and the canceled procedure the event is deemed reportable.

• Brand Name: BIOPSY FORCEPS, FLEXIBLE, 1 MM
• Common Device Name: BIOPSY FORCEPS, FLEXIBLE, 1 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22524215
• Report Number: 2020550-2025-01224
• Device Sequence Number: 7951051
• Product Code: EOQ
• UDI-Device Identifier: 04048551050248
• UDI-Public: 04048551050248
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025
• Report Date (Section F): 07/16/2025

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: 11003MA
• Device Catalogue Number: 11003MA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown