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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.0 ULTEM KOH-EFF
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COOPERSURGICAL, INC. STERILE 3.0 ULTEM KOH-EFF Back to Search Results
Model Number AD750-KE30
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed.(b)(4).
 
Event Description
Per telephone conversation with cooper rep- "the cup on the device chipped off during procedure".Follow-up with rep stated ".I did not observe first hand, but the scrub tech who was hands-on with the delineator saw that there was a speck of blue near the vaginal cuff as they were suturing.The first assist picked the speck of blue koh cup and removed it from the patient through the assist port.When cleaning of his instrument the piece observed and captured was lost." (b)(4).
 
Event Description
Per telephone conversation with cooper rep- "the cup on the device chipped off during procedure".Follow-up with rep stated ".I did not observe first hand, but the scrub tech who was hands-on with the delineator saw that there was a speck of blue near the vaginal cuff as they were suturing.The first assist picked the speck of blue koh cup and removed it from the patient through the assist port.When cleaning of his instrument the piece observed and captured was lost." ref e-complaint - (b)(4).
 
Manufacturer Narrative
Reference: e-complaint - (b)(4).Investigation: x-initiated manufacturer's investigation.X-review dhr.X-inspect returned samples.Analysis and findings: a review of the device history record for lot no.275-18 was made under wo (b)(4) indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.The complaint unit was returned, however the small piece of plastic was lost as indicated in the complaint initiation.It is unknown is the small piece of plastic found by customer matches that of the ultem cup.A previous investigation affirmed by the resident cmo that it is possible to have small pieces separate from cup to occur while using the device along with electrocautery devices when the user maintains the energized electrocautery tip against the cup for a time longer than necessary to separate the tissue.The evidence on the koh-efficient cup is not out of the ordinary and commonly found on other used devices and may be attributed to incorrect user technique (see attached img_0216.Jpg for images of the marks on the rim of the cup).This device is oem manufactured for csi which sends it to another outside contractor for sterilization and distributes it from fg warehouse trumbull.All devices are 100% inspected by the oem before being shipped to csi in trumbull, ct.Correction and/or corrective action: corrective action is not warranted as this event result has been acknowledged as normal occurrence by the csi resident cmo.Per the ufmea (rmf0004-ufmea) the rpn number associated with small pieces separating from cup is at 108, and is not subject to further review and analysis per sop-eng-322.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
 
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Brand Name
STERILE 3.0 ULTEM KOH-EFF
Type of Device
STERILE 3.0 ULTEM KOH-EFF
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key8740262
MDR Text Key149506677
Report Number1216677-2019-00185
Device Sequence Number1
Product Code HEW
Combination Product (y/n)N
PMA/PMN Number
K143650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/01/2021
Device Model NumberAD750-KE30
Device Catalogue NumberAD750-KE30
Device Lot Number275-18
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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