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

Model Number LF5637

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/17/2021

Event Type  malfunction  

Event Description

Narrative from staff: the ligasure retractable l-hook laparoscopic sealer/divider 5mm-37cm ref# (b)(4) did not work appropriately during surgery.The device would burn, you could see the tissue bubbling and would not then go through the seal cycle.When the tissue was released from the jaws it was not fully cauterized/sealed and there was more bleeding than normal.The disposable handpiece was switched out and the new one immediately began working appropriately.The generator used with both handpieces was the covidien valleylab ft10 ref#(b)(4).The monopolar settings were cut:30 coag:30.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12576152
• MDR Text Key: 274793872
• Report Number: 12576152
• Device Sequence Number: 1
• Product Code: GEI
• 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: 09/21/2021

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: LF5637
• Device Catalogue Number: LF5637
• Device Lot Number: 10480252X
• 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: 09/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 108