MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 0250070500

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

When suction/irrigation was spiked in saline, the tubing was leaking.No impact on the patient, it was done prior to the procedure.

• Brand Name: STRYKEFLOW
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 6939788
• MDR Text Key: 88942253
• Report Number: 6939788
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/06/2019
• Device Model Number: 0250070500
• Device Catalogue Number: 250-070-500
• Device Lot Number: 17187FG2
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 101