MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, AARDVARK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	0279251101
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Burn, Thermal (2530); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the patient was burned and the device was continuously activating.
Event or Problem Description
It was reported that the patient was burned and the device was continuously activating.
Additional Manufacturer Narrative
Alleged failure: burn injury.Probable root cause: heat can result from insufficient suction which can result from: inadequate hospital suction, leak, bad connection to hospital suction line clogging caused by suction path blockage, lower electrode mass due to variation in electrode thickness or opening cut.Use error: the product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.H3 other text: 81.

• Brand Name: RF 2 PROBES, AARDVARK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11398501
• Report Number: 0002936485-2021-00120
• Device Sequence Number: 3286625
• Product Code: GEI
• UDI-Device Identifier: 07613327056884
• UDI-Public: 07613327056884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0279251101
• Device Catalogue Number: 0279251101
• Device Lot Number: 20083AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other