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).

• 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
• MDR Report Key: 16380585
• Report Number: 2020550-2023-00042
• Device Sequence Number: 6327134
• Product Code: GCJ
• UDI-Device Identifier: 04048551425688
• UDI-Public: 4048551425688
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 02/15/2023
• Report Date (Section F): 02/14/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2023
• 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