MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER FLOW 2

Catalog Number 250-070-520

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/02/2017

Event Type  malfunction  

Event Description

This pt came to surgery for a lap-chole.When changing out the irrigation bag, the suction irrigator tubing came apart from the battery part of the equipment.A new irrigator was opened and used without further complications.

• Brand Name: STRYKER FLOW 2
• Type of Device: STRYKER FLOW 2
• Manufacturer (Section D): STRYKER ENDOSCOPY; san jose CA 95138
• MDR Report Key: 6968221
• MDR Text Key: 90106890
• Report Number: MW5072872
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2019
• Device Catalogue Number: 250-070-520
• Device Lot Number: 17147FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR