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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKEFLOW 2 LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER INSTRUMENTS STRYKEFLOW 2 LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 250-070-500
Device Problems Material Twisted/Bent (2981); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2020
Event Type  Malfunction  
Event Description

The tip of the irrigator was bent when it came out of the package therefore, could not be inserted into the bag of saline. Fda safety report id# (b)(4).

 
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Brand NameSTRYKEFLOW 2
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER INSTRUMENTS
kalamazoo MI 49002
MDR Report Key10167415
MDR Text Key195749372
Report NumberMW5095052
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 06/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250-070-500
Device LOT Number19311FG2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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