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

Catalog Number	0279351250
Health Effect - Clinical Codes	Burn, Thermal (2530); Electric Shock (2554)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the surgeon got a small shock from the probe and let it go, dropping it onto the patient which caused a burn.There is no information to indicate a serious injury as a result of the shock.Note that the surgeon was able to successfully finish the surgery using a shaver.
Additional Manufacturer Narrative
Alleged failure: error 11 message.The probe appeared to be continuously triggering.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a leak which permitted water to ingress into handle where the electrical components are, causing a short circuit which contributes the unit to fail (continuous activation).Other possibilities a short due inadequate gluing operation on the internal suction tube and suction shaft.Footswitch pedal stuck on firing position, button inadvertently pressed.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 surgeon got a small shock from the probe and let it go, dropping it onto the patient which caused a burn.There is no information to indicate a serious injury as a result of the shock.Note that the surgeon was able to successfully finish the surgery using a shaver.

• 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: 7724073
• Report Number: 0002936485-2018-00550
• Device Sequence Number: 13841288
• Product Code: GEI
• UDI-Device Identifier: 07613327056983
• UDI-Public: 07613327056983
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0279351250
• Device Lot Number: 17229AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other