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

Model Number 0250070500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Event Description

Intraoperatively, it was discovered that the stryker suction/irrigation device was leaking a brown tinged liquid from the devices battery/pump unit.It was obvious that the irrigate (heparinized normal saline) connected to the device was leaking internally and not at the irrigate connection spike.The unit was replaced to prevent the possibility of contaminated irrigate being used in the patient.The procedure was completed without further incident or obvious harm to the patient.

• Brand Name: STRYKEFLOW
• Type of Device: LAPAROSCOPE, GENERAL, & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 6763000
• MDR Text Key: 81689549
• Report Number: 6763000
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/05/2019
• Device Model Number: 0250070500
• Device Catalogue Number: 250-070-500
• Device Lot Number: 17125FG2
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 68 YR