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

Model Number	0250070530
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The stryker strykeflow disposable suction/irrigator single spike tubing was leaking fluid onto the field.This is one of many events in which this product has been leaking.This event was the first time in which the tubing was saved to be returned for investigation, therefore, a report was filed.There was no harm to the patient and the procedure was completed as planned.Manufacturer response for electrosurgical, cutting coagulation accessories, strykeflow (per site reporter).The device will be returned to the manufacturer for failure analysis.Any correspondence will be shared.

• Brand Name: STRYKEFLOW
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 8188934
• Report Number: 8188934
• Device Sequence Number: 13943346
• 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): 12/20/2018
• Report Date (Section F): 12/20/2018

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: 18143FG2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65
• Date Report Sent to FDA: 12/20/2018