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

Lot Number 202204254

Device Problems Loss of or Failure to Bond (1068); Grounding Malfunction (1271); Sparking (2595)

Patient Problem Electric Shock (2554)

Event Date 11/20/2022

Event Type  malfunction  

Event Description

Current grounding pads that were being used do not adhere adequately to a patient's skin.It was witnessed a patient under general anesthesia ¿ her entire body jump having been shocked by the grounding pad.The contact indicator on the erbe was green indicating there was good contact.I also witnessed a spark coming from the cord attached to grounding pad on patient at the time of the shock.Thankfully the patient's skin was not burned.The skin looked perfectly normal when grounding pad was removed.

• Brand Name: SUREFIT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16042017
• MDR Text Key: 306071198
• Report Number: 16042017
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 202204254
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Sex: Female