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

Model Number	495TIP
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved was not returned for evaluation, and the customer has indicated that there is currently no plan to return the product for evaluation.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that there was an issue with the product (495tip - fiber optic light cable, 300cm, ø4,8mm).During our investigation of a patient burn incident that occurred during a lap chole case, the customer mentioned she was told that the exact same type of burn had occurred during a previous lap chole case the week prior (an approximately dime-sized burn below the belly button).Customer also believes that in this case, the burn reddened and it didn't blister but was unable to obtain any further details about this previous case.This complaint involves a total of 3 items (complaint numbers: (b)(4), (b)(4), (b)(4) of which (b)(4) is probably the cause of the burn.The associated devices are mentioned in concomitant medical products.
Additional Manufacturer Narrative
The product involved was not returned for evaluation, and we have been unable to obtain further details about this event.Our ifu contains a warning to avoid direct tissue contact with the distal end, as well as with the light port of the telescope and the light cable, and to never allow the endoscope to rest on the patient or come into direct contact with surgical accessories.This event is filed under internal complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM
• Common Device Name: FIBER OPTIC LIGHT GUIDE CABLE
• 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
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15894363
• Report Number: 9610617-2022-00302
• Device Sequence Number: 6689092
• Product Code: FCW
• UDI-Device Identifier: 04048551004401
• UDI-Public: 4048551004401
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 495TIP
• Device Catalogue Number: 495TIP
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 26046BRA - HOPKINS® STRAIGHT FWD RUBINA NIR/ICG 3; 26046BRA - HOPKINS® STRAIGHT FWD RUBINA NIR/ICG 3; TL400 - COLD LIGHT FOUNTAIN LED LIGHT P; TL400 - COLD LIGHT FOUNTAIN LED LIGHT P
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown