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

Model Number	33310ML
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insert kelly grasping forceps, jaws part broke during operation kelly insert grasping forceps was broken during the operation, surgeon luckily find the broken parts in the abdomen and could be removed via the trocar opening.No injuries on patient, only delay in operating time.
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).
Additional Manufacturer Narrative
During the investigation it was found that the product is broken in the distal area of the tie rod, at the thinning between the joint surfaces.Traces of corrosion can be seen in the broken area.Corrosion can also be seen on the broken surface, so it can be assumed that this has spread over time and thus weakened the material, the corrosion is due to incorrect preparation.The item also shows signs of age.The ifu refers to the relevant points.As stated in the ifu the device must be visually inspected for cleanliness, completeness, damage, and dryness, and damaged or corroded medical devices must be withdrawn from use.The event is filed under internal karl storz complaint id: (b)(4).
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).

• Brand Name: 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
• MDR Report Key: 17808862
• Report Number: 9610617-2023-00268
• Device Sequence Number: 6727475
• Product Code: GCJ
• UDI-Device Identifier: 04048551134443
• UDI-Public: 4048551134443
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 11/23/2023

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: 33310ML
• Device Catalogue Number: 33310ML
• Device Lot Number: TU31
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 11/21/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/09/2023; 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• 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