MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SELF-ADHESIVE NEUTRAL ELECTRODE, PATIENT PLATE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0406-650-205

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that a patient sustained burns at the grounding pad site.It is reported that the patient was not shaved and there was not good adhesive contact/connection with the grounding pad.The procedure was completed successfully with a 5-minute delay to change the grounding pad.Triple antibiotic ointment and dressing was applied to promote healing and prevent infection.During follow-up on december 28, the patient was healing without complication.

• Brand Name: SELF-ADHESIVE NEUTRAL ELECTRODE, PATIENT PLATE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13253319
• MDR Text Key: 283781078
• Report Number: 3015967359-2022-00048
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406-650-205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2021
• 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
• Treatment: 8400000000 MG2 CONSOLE SN (B)(4); 8400800000 MG2 SPLITTER CABLE SN (B)(4)