MAUDE Adverse Event Report: RELIGN CORPORATION RELIGN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number R-10023

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Upon removing or (operating room) drapes at completion of procedure 1 cm x 4 cm superficial burn noted below port on patients shoulder from relign device.

• Brand Name: RELIGN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): RELIGN CORPORATION
• MDR Report Key: 19051457
• MDR Text Key: 339629275
• Report Number: MW5153568
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/02/2024

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 Catalogue Number: R-10023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White