MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, 50-S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279351250
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the probe was continuously activating.The procedure was completed successfully with no impact to the patient.
Additional Manufacturer Narrative
Alleged failure: per sales rep, turned it on and it wouldn't turn off.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the detachment of the suction tube to the suction shaft causing a leak internally which creates a short.Inadequate gluing operation on the suction tube and suction adapter, the user accidentally submerges the device in saline.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the probe was continuously activating.The procedure was completed successfully with no impact to the patient.

• Brand Name: RF 2 PROBES, 50-S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7887298
• Report Number: 0002936485-2018-00609
• Device Sequence Number: 2488860
• Product Code: GEI
• UDI-Device Identifier: 07613327056983
• UDI-Public: 07613327056983
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0279351250
• Device Lot Number: 18033AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1