MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT

Model Number	33310A
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	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that karl storz forcep's tip broke off during a laparoscopic appendectormy procedure.The tip was retrieved successfuly using x-ray.No additional information was provided.
Additional Manufacturer Narrative
Attempts are being made to request product return for evaluation.If new information or product would be available for further evaluation, a supplemental would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction in sections b1: this incident was deemed as "adverse event" due to the fact that an x-ray had to be performed in order to retrieve the broken tip.However, we previously submitted this medwatch only as "produt problem".We therefore will submit this correction now retrospectively.Correction in d4: updated the udi number.Also, per investigation by the manufacturing site: the affected instrument was not returned for investigation.Therefore, an investigation of the instrument was not possible and a definite root cause cannot be determined.Most likely root cause: operator error due to overloading and / or incorrect reprocessing.According to the customer the tip broke off during procedure.It is concluded that the most probable root cause was a mechanical damage due to overloading, which then led to complete breakage over time.The ifu warns against overloading.As no article was sent in, a more detailed investigation cannot be carried out.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• 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 ; 4242188247
• MDR Report Key: 18698078
• Report Number: 9610617-2024-00038
• Device Sequence Number: 8332261
• Product Code: GCJ
• UDI-Device Identifier: 04048551133989
• UDI-Public: 04048551133989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 33310A
• Device Catalogue Number: 33310A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 78 KG