MAUDE Adverse Event Report: COVIDIEN LP LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LF1837

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

We had a ligasure instrument that was not functioning appropriately, there was an issue with the mouth, the end piece not coming together correctly.The doctor was able to continue the case without utilizing it further an there was no harm to the patient.Device and packaging saved for quality.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11357776
• MDR Text Key: 232817645
• Report Number: 11357776
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705883
• UDI-Public: (01)10884521705883(17)250403(10)01220076X
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2021

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
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 01220076X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Weight: 84