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

Model Number	26606BCA
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lap hiatal hernia repair procedure on (b)(6) 2024, the surgical technician (cst) was holding the tipcam where the light cord plugs into the proximal end of the scope.The cst burned her finger on the junction where the light cord attaches to the light source.This caused a slight skin discoloration on her finger, and no treatment was deemed necessary then.They were able to complete the procedure without any further incidents.According to the customer, the cst is doing fine now.
Additional Manufacturer Narrative
This incident was deemed as an "adverse event".However we failed to file the importer medwatch, and therefore will submit the importer medwatch now retrospectively.This event is filed under internal complaint id (b)(4).A 495tip (fiber optic light cable, 300 cm, ø4.8 mm) was used together with this device during the incident as a concomitant item (as listed in section d10), which was filed under another internal complaint id (b)(4).

• Brand Name: TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: TIPCAM1 RUBINA
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19785970
• Report Number: 2020550-2024-00125
• Device Sequence Number: 8655035
• Product Code: GCJ
• UDI-Device Identifier: 04048551425688
• UDI-Public: 4048551425688
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/19/2024
• Report Date (Section F): 07/19/2024

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: 04/10/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 495TIP (FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown