MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	0250070530
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While doing a laparoscopic sleeve gastrectomy, the surgeon was using the stryker strykeflow suction irrigation tubing.During the case, saline began to leak from the hand piece causing fluid to flow onto the patient and the surgeon.The device was switched out and the procedure was completed as planned.No harm came to the patient.Several similar occurrences have been reported from the or surgical staff, however, no samples have been saved post-operatively.If a future sample is saved, it will be returned to the manufacturer.

• Brand Name: STRYKEFLOW
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 2825 airview boulevard; portage MI 49002
• MDR Report Key: 8008726
• Report Number: 8008726
• Device Sequence Number: 13811457
• Product Code: GEI
• UDI-Device Identifier: 07613327061352
• UDI-Public: (01)07613327061352
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2018
• Report Date (Section F): 10/15/2018

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 Model Number: 0250070530
• Device Catalogue Number: 250-070-530
• Device Lot Number: 18102FG2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/15/2018