MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 30°

Model Number	26605BA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during a robotic laparoscopic hartmann's reversal procedure, at the time of splenic flexure mobilization, an image quality issue suddenly occurred on the endoscope while the surgeon was operating.The image changed, prompting the withdrawal, cleaning, and reinsertion of the endoscope was done but the issue persisted.The storz system was then rebooted by turning off both the bottom and top units and turned them back on, but the issue remained unresolved.Finally, a new endoscope was used to resolve the issue.There was no patient injury.No negative impact in state of health reported.New information received: there was a prolongation of procedure of 90 minutes.Due to that, a report is required.

• Brand Name: TIPCAM 1 S 3D LAP, 30°
• Common Device Name: TIPCAM 1 S 3D LAP, 30°
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24945595
• Report Number: 2020550-2026-00663
• Device Sequence Number: 9890756
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 04048551347843
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026
• Report Date (Section F): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26605BA
• Device Catalogue Number: 26605BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown