MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 RUBINA, 4K,3D; 4K CAMERA HEAD

Model Number	26606BCA
Medical Device Problem Codes	Use of Device Problem (1670); Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As per manufacturer incident report # (b)(4) we received from the factory in (b)(6): while preparing for laparoscopic surgery, 26606bca that was connected to the light source device(tl400) was placed on the patient's body.A burn (10mm in diameter) occurred on the patient's chin due to the light emission from the distal tip of the telescope.
Additional Manufacturer Narrative
The medical device has been inspected by the technical service team of karl storz endoscopy (b)(6) after the incident and it could be confirmed that there was no functional defect of the device.The device is currently back in use and working normally at the hospital.The adverse event occurred due to a use error.User training was re-implemented.

• Brand Name: TIPCAM1 RUBINA, 4K,3D
• Common Device Name: 4K CAMERA HEAD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188100
• MDR Report Key: 14799204
• Report Number: 9610617-2022-00103
• Device Sequence Number: 6108414
• Product Code: GCJ
• UDI-Device Identifier: 04048551425688
• UDI-Public: 4048551425688
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26606BCA
• Device Catalogue Number: 26606BCA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown