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

Catalog Number 0279351400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: motor stays on and none of the buttons respond 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), inadequate gluing/welding of core to handle, use error.

Event Description

It was reported that the motor had continuous activation during a procedure.The surgery was completed successfully.

• 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: roomi banerjee dua ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7636032
• MDR Text Key: 112315253
• Report Number: 0002936485-2018-00503
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057041
• UDI-Public: 07613327057041
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0279351400
• Device Lot Number: 18068AE2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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