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

Model Number 05-0760LED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: LED LIGHT SOURCE, BATTERY POWERED
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10809121
• MDR Text Key: 216954816
• Report Number: 1717344-2020-01378
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 04250480107645
• UDI-Public: 04250480107645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 05-0760LED
• Device Catalogue Number: 05-0760LED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1