MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS; CLICKLINE FORCEPS INSERT

Model Number	33310HM
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	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a small pin from the inside of the device came off and was lost in the abdomen when the instrument was used during a procedure.Xray were called to help to locate the pin.The pin was located and successfully retrieved.The instrument was in working order prior to this.It was checked by the scrub nurse and used by the surgeon before the pin came loose.
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).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the product was returned on (b)(6) 2024.The investigation of the product was completed on (b)(6) 2024.Both products are aged.The metal outer sheath was produced in 2018 and the clickline forceps insert was produced in 2004.A visual inspection was carried out.There are traces of use on the surface of the shaft corresponding to its age.The rivet in the joint was sheared off due to excessive force, as shown by the material thrown up at the holes.Material fatigue can occur over time due to the age and the corresponding number of reprocessing.Corrosion can also be seen on the contact surfaces of the joints.The ifu refers to the relevant point to check the functionality prior to use.With a sufficient check a loose pin would have been detected prior to the surgery.The cause of the error is due to user fault.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS
• 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: 19837304
• Report Number: 9610617-2024-00228
• Device Sequence Number: 20489974
• Product Code: GCJ
• UDI-Device Identifier: 04048551134283
• UDI-Public: 04048551134283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 08/19/2024

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: 33310HM
• Device Catalogue Number: 33310HM
• Device Lot Number: IF1515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/16/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/02/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown