MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC FORCEPS, BIOPSY, LAPAROSCOPE, RIGID; CLICKLINE FORCEPS INSERT

Model Number	33310CC
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that the tip of a laparoscopic instrument insert dropped during use in a live patient case.Broken tip was immediately recovered and removed from the cavity; faulty instrument was put aside and replaced with another laparoscopic instrument.
Additional Manufacturer Narrative
Result of investigation: since we had no product (33310c) and no serial number to examine, we could not carry out a thorough investigation.Based on our examination of other cases with the same or similar cause of failure as described by the customer, we assume that the customer used the product improperly.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPIC FORCEPS, BIOPSY, LAPAROSCOPE, RIGID
• Common Device Name: CLICKLINE FORCEPS INSERT
• 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: 20599439
• Report Number: 9610617-2024-00431
• Device Sequence Number: 8803981
• Product Code: GCJ
• UDI-Device Identifier: 04048551134108
• UDI-Public: 04048551134108
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K935071
• 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
• Report Date (Section B): 12/03/2024

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: Health Professional
• Device Model Number: 33310CC
• Device Catalogue Number: 33310CC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2005
• 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
• Patient Sex: Unknown