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

Model Number 0279251101

Device Problems Device Remains Activated (1525); Excessive Heating (4030)

Patient Problems Burn, Thermal (2530); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the patient was burned and the device was continuously activating.

Event Description

It was reported that the patient was burned and the device was continuously activating.

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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11398501
• MDR Text Key: 234246564
• Report Number: 0002936485-2021-00120
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327056884
• UDI-Public: 07613327056884
• Combination Product (y/n): N
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 0279251101
• Device Catalogue Number: 0279251101
• Device Lot Number: 20083AE2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other