MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM

Model Number	495TIP
Medical Device Problem Codes	Overheating of Device (1437); Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Burning Sensation (4540)
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
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).Item 26606bca (tipcam1 rubina 30°, opal1 nir/icg, 4k 3d) 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).
Additional Manufacturer Narrative
Correction: we have now marked this as adverse event with serious injury.And per evaluation findings by the manufacturing site: according to the customer, the operating technician suffered a burn to his finger during the operation on the connection for the light guide cable on the tipcam optics used.A possible cause of increased heating in this area could be contamination of the light guide socket on the device side or an incorrectly selected light intensity output.The risk of heating and tissue traumatization is described in ifu 97000213v 3.0 - 11/2017.Based on the customer's descriptions, we assume a user error.The evaluation for the requested period from 01.01.2020 - 20.06.2024 resulted in four (4) complaints with a total sales quantity of 17919 units and a resulting rate of 0.02%.No further measures will be initiated.This event is filed under internal complaint id (b)(4).Item 26606bca (tipcam1 rubina 30°, opal1 nir/icg, 4k 3d) 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: FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE
• 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 ; 4242188247
• MDR Report Key: 19234507
• Report Number: 9610617-2024-00126
• Device Sequence Number: 6980464
• Product Code: FCW
• UDI-Device Identifier: 04048551004401
• UDI-Public: 4048551004401
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 495TIP
• Device Catalogue Number: 495TIP
• Device Lot Number: YN26
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26606BCA (TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG,4K 3D)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown