MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA. INC CLICKLINE OUTER SHEATH

Model Number	31300
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported during recent insulation testing, identified arcing in certain areas of the sheathing for the mini laparoscopic instruments.Interestingly, the arcing occurred in the same area across different sheaths within the same tray.
Additional Manufacturer Narrative
The device was returned on june 05, 2025, will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Conclusion summary: the surface of the shaft shows some very deep scratches/damage, which may have been caused by use with trocars or other instruments.Please check the shafts for damage before each use.The above 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 similar complaints; no trend was identified.This event is filed under internal complaint id (b)(4).

• Brand Name: CLICKLINE OUTER SHEATH
• Common Device Name: CLICKLINE OUTER SHEATH
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA. INC; 2151 e. grand avenue; el segundo CA 90245
• Manufacturer (Section G): KARL STORZ ENDOSCOPY-AMERICA. INC; 2151 e. grand avenue; el segundo CA 90245
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245
• MDR Report Key: 22283379
• Report Number: 9610617-2025-01035
• Device Sequence Number: 8875608
• Product Code: GCJ
• UDI-Device Identifier: 04048551333921
• UDI-Public: 04048551333921
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Device Model Number: 31300
• Device Catalogue Number: 31300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 02/25/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown