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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL FILSHIE TUBAL LIGATION SYSTEM; FILSHIE CLIPS
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COOPERSURGICAL FILSHIE TUBAL LIGATION SYSTEM; FILSHIE CLIPS Back to Search Results
Catalog Number AVM-851
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2019
Event Type  Injury  
Event Description
At this point, it was noted by operating room staff, and they informed me, that the clips that had just been applied were expired.As i am unaware of a way to open and remove the clips once they've been deployed; i was unsure if an "expired clip" was somehow less effective than a non-expired one, a new set of "non-expired" clips was opened and new clips were placed right next to the first set of clips, first on the right tube, then on the left tube.Now, each tube has 2 filshie clips on it next to each other at the isthmo-ampullary junction.Fda safety report id# (b)(4).
 
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Brand Name
FILSHIE TUBAL LIGATION SYSTEM
Type of Device
FILSHIE CLIPS
Manufacturer (Section D)
COOPERSURGICAL
MDR Report Key9219980
MDR Text Key163569206
Report NumberMW5090551
Device Sequence Number1
Product Code KNH
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 10/18/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Catalogue NumberAVM-851
Device Lot Number35041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
Patient Weight56
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