MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070443
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was a burn to the patient.Please note the procedure was completed successfully.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: inner sheath and l-tip started to melt during a procedure.The surgeon cauterized the liver when it was not meant to be cauterized.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be, conductive irrigating or aspirating fluid used was inside the distal end, and contacted the probe and the sheath causing the sheath to melt, power set too high.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a burn to the patient.Please note the procedure was completed successfully.

• Brand Name: PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7754591
• Report Number: 0002936485-2018-00567
• Device Sequence Number: 16570372
• Product Code: GCJ
• UDI-Device Identifier: 07613327051872
• UDI-Public: 07613327051872
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• 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): 11/30/2018

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: 0250070443
• Device Lot Number: 18E5379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 11/30/2018
• 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