MAUDE Adverse Event Report: COVIDIEN; ELECTROSURGICAL, CUTTING, COAGULATION

Catalog Number LF1837

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

The sealer did not seal properly.

• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• MDR Report Key: 7361708
• MDR Text Key: 103187577
• Report Number: 7361708
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017,03/08/2018

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: Physician
• Device Expiration Date: 09/05/2022
• Device Catalogue Number: LF1837
• Other Device ID Number: 5MM-37CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR