MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SINGLE FIBER OPTIC CABLE, PINK, 10 FT, ACMI; LIGHT, SURGICAL, FIBEROPTIC

Model Number	SINGLE, 10FT, PINK
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, while using the device the patient experienced second degree burns.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during a surgical procedure at the user facility, while using the device the patient experienced second degree burns.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : no product return per the customer.

• Brand Name: SINGLE FIBER OPTIC CABLE, PINK, 10 FT, ACMI
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11983124
• Report Number: 3015967359-2021-01118
• Device Sequence Number: 13741354
• Product Code: FST
• UDI-Device Identifier: 00816728020202
• UDI-Public: 00816728020202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SINGLE, 10FT, PINK
• Device Catalogue Number: FC1SP
• Device Lot Number: 19120912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1