MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CAP, Ø 37 MM, 30 MM

Model Number	26168ZC
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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).
Event or Problem Description
It was reported that during the procedure the cap came off.Device lost the white part during the operation, due to that the glue was not strong enough.No negative impact in state of health reported.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the technical investigation of the returned product, the following was found: both adhesive joints have come loose.The ceramic bell can be rotated, but it cannot be unscrewed.There is also sufficient adhesive visible at the connection point on the rear.The conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.It can be assumed that the user is at fault here, as the article was subjected to mechanical overload, which caused the adhesive joints to break.Incorrect preparation may also have had a negative effect on the adhesive properties.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CAP, Ø 37 MM, 30 MM
• Common Device Name: CAP, Ø 37 MM, 30 MM
• 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21679545
• Report Number: 9610617-2025-00488
• Device Sequence Number: 18065778
• Product Code: HIH
• UDI-Device Identifier: 04048551318850
• UDI-Public: 04048551318850
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K992027
• 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): 07/10/2025

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: 26168ZC
• Device Catalogue Number: 26168ZC
• Device Lot Number: NM03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 07/03/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/17/2025; 07/10/2025
• 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