MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LTD BOSTON SCIENTIFIC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number DGP-PM2-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/16/2022

Event Type  Injury  

Event Description

It was reported that the patient had a burn from the grounding pad.The grounding pad was discarded.

Event Description

It was reported that the patient had a burn from the grounding pad.The grounding pad was discarded.

Manufacturer Narrative

Correction to the initial and follow-up 1 mdrs in block b5.

Event Description

It was reported that the patient had a burn from the grounding pad.The grounding pad was discarded.No medical treatment outside of the clinic was provided.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16080819
• MDR Text Key: 306495906
• Report Number: 3006630150-2022-07419
• 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: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DGP-PM2-25
• Device Catalogue Number: DGP-PM2-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention