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

Catalog Number	0279351250
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	09/12/2018
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 patient was burnt.
Additional Manufacturer Narrative
Patient was burnt near working port.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be activation of the probe during removal from the joint space, inadequate suction causing hot saline to leak from the joint space.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient was burnt.

• 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: 7952888
• Report Number: 0002936485-2018-00639
• Device Sequence Number: 13560050
• Product Code: GEI
• UDI-Device Identifier: 07613327056983
• UDI-Public: 07613327056983
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/17/2018

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: 18050AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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