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

Model Number 0279251101

Device Problem Device Remains Activated (1525)

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 got burned, in addition to the malfunction of continuous activation.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: wand activated without pedal or button.Probable root cause: probe short, button stuck on firing position, fluid ingress, suction tube cut, button inadvertently pressed, damaged insulation, probe bender used to bend nonbendable probe, user accidentally submerges device, inadequate gluing operations (tip and core/lumen) or inadequate gluing/welding of core to handle console error use error h3 other text : 81.

Event Description

It was reported that the patient got burned, in addition to the malfunction of continuous activation.

• 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: 11225116
• MDR Text Key: 228604645
• Report Number: 0002936485-2021-00052
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327056884
• UDI-Public: 07613327056884
• Combination Product (y/n): N
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other