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

Catalog Number 0279401100

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device was continuously activating.

Event Description

It was reported that the device was continuously activating.

Manufacturer Narrative

The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: it continued to burn when it wasn't suppose to.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be probe short possibly due inadequate gluing operation on the suction tube and suction adapter to cause a leak/saline ingress internally which creates a short, the user accidentally submerges the device in saline.Other possibilities button or footswitch pedal stuck on firing position, button inadvertently pressed.

• 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
• MDR Report Key: 7557938
• MDR Text Key: 109746996
• Report Number: 0002936485-2018-00469
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057027
• UDI-Public: 07613327057027
• 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: 11/13/2018

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 Catalogue Number: 0279401100
• Device Lot Number: 17286AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1