MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER N/A; LED LIGHT SOURCE, BATTERY POWERED

Model Number	05-0760LED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a 4k procedure, the scrub nurse neglected to connect a laparoscope, turned the led light source and placed the cable on the drape top of the patient.After the procedure concluded, it was noted that the cable tip had burned a hole in the drape and the burn went through all the way creating a burn on the patient approx.1/4 " in the pelvic area.

• Brand Name: N/A
• Common Device Name: LED LIGHT SOURCE, BATTERY POWERED
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10809121
• Report Number: 1717344-2020-01378
• Device Sequence Number: 17094553
• Product Code: NTN
• UDI-Device Identifier: 04250480107645
• UDI-Public: 04250480107645
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: Health Professional
• Device Model Number: 05-0760LED
• Device Catalogue Number: 05-0760LED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1