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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPER SURGICAL, INC. SKW DEEP SCROTALRETRACTABLE SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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COOPER SURGICAL, INC. SKW DEEP SCROTALRETRACTABLE SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number 72403867
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Event Description
It was reported that during a sling procedure, when the operating room head nurse was about to open the skw disposable retractor system a hair inside the sterile packaging was detected.Therefore, the skw was not utilized.The procedure was completed utilizing retractors from the hospital.The surgery was successfully completed without patient complications.
 
Event Description
It was reported that during a sling procedure, when the operating room head nurse was about to open the skw disposable retractor system a hair inside the sterile packaging was detected.Therefore, the skw was not utilized.The procedure was completed utilizing retractors from the hospital.The surgery was successfully completed without patient complications.
 
Manufacturer Narrative
Investigation summary: with all the available information boston scientific concludes that the reported foreign matter present in packaging was confirmed through visual inspection.The events leading to the foreign material being sealed into the packaging could not be confirmed.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: visual inspection of the packaging was completed.A hair was identified and confirmed in the sterile packaging of the skw disposable retractor system.Labeling review: a review of the device instructions for use (ifu) is not required as there is no indication of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
 
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Brand Name
SKW DEEP SCROTALRETRACTABLE SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
COOPER SURGICAL, INC.
MDR Report Key12343561
MDR Text Key267305280
Report Number2124215-2021-24979
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
PMA/PMN Number
K053371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72403867
Device Catalogue Number72403867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Initial Date Manufacturer Received 07/28/2021
Initial Date FDA Received08/19/2021
Supplement Dates Manufacturer Received10/28/2021
Supplement Dates FDA Received11/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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