MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, 90-S MAX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0279401100

Device Problems Continuous Firing (1123); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device continuously activated and sparked.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: unintended energy delivered 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.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the device continuously activated and sparked.

• Brand Name: RF 2 PROBES, 90-S MAX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16111049
• MDR Text Key: 307155388
• Report Number: 0002936485-2023-00013
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057027
• UDI-Public: 07613327057027
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0279401100
• Device Catalogue Number: 0279401100
• Device Lot Number: 22126AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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