MAUDE Adverse Event Report: MICROLINE HANDLE LAPAROSCOPIC SHEAR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	3904
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Laparoscopic shears used during surgery malfunctioned and melted the shielding on the shaft causing a burn lesions to the uterus requiring sutures and burn lesion removal.This is a reusable instrument.However, the tip of the instrument is disposable.The facility does reprocess this device.

• Brand Name: MICROLINE HANDLE LAPAROSCOPIC SHEAR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• MDR Report Key: 18969267
• Report Number: MW5153083
• Device Sequence Number: 12404929
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3904
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American