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

Model Number	0279350501
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	12/10/2019
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 the patient was burned due to the device arcing.
Additional Manufacturer Narrative
Alleged failure: the energy/heat was "arcing" and heating up on the head and neck of the tool the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be the whole tip was not completely submerge in saline during activation, withdrawing the probe during application of power, stack up discrepancy between the outer lumen and tip assembly which all may cause a short circuit due to water ingression.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported the patient was burned due to the device arcing.

• Brand Name: RF 2 PROBES, HOOK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9555956
• Report Number: 0002936485-2020-00005
• Device Sequence Number: 2461066
• Product Code: GEI
• UDI-Device Identifier: 07613327056938
• UDI-Public: 07613327056938
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2020

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 Model Number: 0279350501
• Device Catalogue Number: 0279350501
• Device Lot Number: 18338AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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
• Patient Age: 52 YR
• Patient Weight: 115