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

Model Number	33310C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that insertion of the third (last) port, the consultant surgeon used the johan forcep to hold the sheath so that he can advance the port.While the surgeon was doing this, one of the jaws of the forcep broke off.One jaw was completely separated from the other jaw and was missing in the peritoneal area.The missing jaw was located and retrieved by the consultant surgeon without any further problem and time delay.
Additional Manufacturer Narrative
The item 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
The reported device was evaluated.Per physical inspection of the device, one branch of the pliers insert was broken off.Traces of corrosion could be seen in the entire area, as well as on the break point.It was possible that due to overload a mechanical pre-damage occurred e.G.A little crack.The material might have been weakened over the years by the corrosion, including at the point of breakage, which led to the branch breaking.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: 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: 18357814
• Report Number: 9610617-2023-00398
• Device Sequence Number: 6944382
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• 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): 02/23/2024

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: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 02/22/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/05/2024; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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