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

Model Number LF5644

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2022

Event Type  malfunction  

Event Description

During the case, the ligasure retractable l hook sealer/divider the shaft of the device broke when inside a trocar that was in the patient.Device was removed from patient and new device was obtained to finish the case.It did not appear that there were any pieces of the shaft missing or in the patient or trocar.Operative report: optiview trocar was inserted under direct vision of the laparoscope.Following this, additional trocars were then placed in preparation for surgical resection.At this time, initial inspection of the abdomen showed no evidence of carcinomatosis.Liver appeared free of any obvious disease other than some fatty liver disease.At this point, we began freeing up some of the adhesions of the omentum to the left colon.Splenic flexure was then able to be identified.At this point, we used a medial to lateral dissection from the mesentery using the ligasure device to identify the ligament of treitz.The inferior mesenteric vein was identified, circumferentially cleared and clipped and divided with the ligasure device.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15743070
• MDR Text Key: 303165238
• Report Number: 15743070
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5644
• Device Lot Number: 21470027X
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: Black Or African American