MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D; RIGID VIDEO LAPAROSCOPE

Model Number	26606BCA
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to kst that after (almost) 2 hours of use, the handle gets very hot and a doctor developed a red spot of burned tissue after use.
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
The present optics has normal signs of use.The condition of the optics is good.The distal end of the tipcam has no visually visible damage.The handle shows superficial discoloration at the distal end which is also clearly visible in the "tipcam" logo as gray dots.The distal cover glasses are clear and undamaged.The system itself is tight.No leakage is visible at the junction between the cable connector and the housing.The connector has no damage or breaks on the circuit board.The error described by the customer could not be reproduced during the check.The tipcam was connected for several hours and no elevated operating temperature was detected that could have caused redness/burns on the hand (as described by the customer).The surface in the grip area shows a color change that indicates a chemical attack on the surface.To what extent chemical residues on the handle in connection with the redness of the user's hand are related is currently not comprehensible.The tipcam corresponds to the valid specifications and no functional error could be detected.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: TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: RIGID VIDEO LAPAROSCOPE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16380568
• Report Number: 9610617-2023-00042
• Device Sequence Number: 20383840
• Product Code: GCJ
• UDI-Device Identifier: 04048551425688
• UDI-Public: 4048551425688
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K201526
• 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): 04/19/2023

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: 26606BCA
• Device Catalogue Number: 26606BCA
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 04/13/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/16/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown