MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 90-S ACCELERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0279351400

Device Problems Continuous Firing (1123); Failure to Shut Off (2939)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that the device was continuously activating.

Manufacturer Narrative

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

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.Alleged failure: could not be turned off.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: refer to rsk10684 for risk outputs associated with rf energy to probe for the serfas energy console.Refer to rsk10642 for risk outputs associated with rf signal to handpiece for crossfire and crossfire ii consoles use error.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that the device was continuously activating.

• Brand Name: 90-S ACCELERATOR
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14015999
• MDR Text Key: 294488167
• Report Number: 0002936485-2022-00163
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057041
• UDI-Public: 07613327057041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0279351400
• Device Catalogue Number: 0279351400
• Device Lot Number: 21158AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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