MAUDE Adverse Event Report: COVIDIEN LLC LIGASURE MARYLAND JAW WITHOUT NANO-COATING; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,

Model Number LF1937

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

Event Date 04/23/2024

Event Type  malfunction  

Event Description

While attempting to activate a stryker reprocessed ligasure maryland jaw device to control bleeding from an ectopic pregnancy, the covidien esu #42 would not accept the device.The machine alarmed and a e416 error message appeared with the banner "uknown instrument" and message "instrument not recognized, replace instrument".A new non-reprocessed covidien device was retrieved, plugged in, and functioned as expected.Total time to replace instrument was approximately 90 seconds.

• Brand Name: LIGASURE MARYLAND JAW WITHOUT NANO-COATING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,
• Manufacturer (Section D): COVIDIEN LLC; mansfield, MA
• MDR Report Key: 19212933
• MDR Text Key: 341539957
• Report Number: MW5154434
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2024

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: LF1937
• Device Lot Number: 141212505
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White