MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT; INSERT,BOWEL GRASPER,FENESTRAT

Model Number	33310C
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	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that parts of the device broke off in the patient.The broken piece was removed, and an x-ray was not required.Technical evaluation found scratches on the surface near wear the piece broke off and slightly bend shaft that might have led to the breakage.In all cases described above no patient, user or third was harmed.
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.Evaluation was done as part of capa 22-0074 (retrospective review).The complaints describe issues with (b)(4) (insert,bowel grasper,fenestrat).A complaint history review (for the last two years) yielded six complaints that describe similar mal-functions.In all cases that resulted in filing an mdr the item in use broke during a procedure and the pieces needed to be retrieved from the patient's body.It was determined that the complaint is reportable because the risk for serious injury is not excluded if the event were to recur.Two complaint investigations also refer to complaints (review timeframe between 2020-11 and 2022-11) that were con-sidered as similar and caused or contributed to a death or serious injury or required medical inter-vention.Based on this, the complaints are considered reportable.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: INSERT,BOWEL GRASPER,FENESTRAT
• 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: 17647543
• Report Number: 9610617-2023-00226
• Device Sequence Number: 7380656
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: WV01
• 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: 08/31/2021
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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