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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.0CM
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COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.0CM Back to Search Results
Model Number KC-RUMI-30
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2019
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.
 
Event Description
"the cuff on the device deflated during laparoscopic hysterectomy.As a result it was not possible to maintain a satisfactory pneumoperitoneum and surgery converted to a vaginal approach in order to complete.No injury to the patient although procedure slightly lengthened by the difficulties and set up of additional equipment.Cuff was inspected after the case and a small hole was noted in the cuff where the fluid was leaking from." (b)(4).
 
Manufacturer Narrative
(b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned, x-review dhr.Distribution history: the complaint product was manufactured at csi on 11/28/2017 under work order (b)(4).Manufacturing record review: dhr - 238615 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.History complaint review: a review of the attached 2-year complaint history showed similar reported complaint conditions were the cuff (occluder) started leaking during the procedure.Product receiptl the complaint product has not been returned to coopersurgical.Visual eval.: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional eval.: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, the complaint condition is very similar to other complaints as mentioned earlier.In those complaints, the device started leaking during the procedure.Root cause: no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation nor verification.It should be noted that the dfu of the device ((b)(4)) states that the device should be tested by inflation of the occluder with 20-60 cc of saline prior to usage.The complaint states that the device was leaking during the procedure, indicating that the product was tested and was working prior to the leak.A possible root cause of this may be that the occluder encountered a sharp object during usage.Other complaints of occluder leakage were also attributed to the product encountering a sharp object when complaint product was returned for investigation.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
 
Event Description
"the cuff on the device deflated during laparoscopic hysterectomy.As a result it was not possible to maintain a satisfactory pneumoperitoneum and surgery converted to a vaginal approach in order to complete.No injury to the patient although procedure slightly lengthened by the difficulties and set up of additional equipment.Cuff was inspected after the case and a small hole was noted in the cuff where the fluid was leaking from." ref (b)(4).
 
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Brand Name
KOH-EFFICIENT,RUMI,3.0CM
Type of Device
KOH-EFFICIENT,RUMI,3.0CM
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key9198168
MDR Text Key168208973
Report Number1216677-2019-00277
Device Sequence Number1
Product Code HEW
Combination Product (y/n)N
PMA/PMN Number
K954311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date11/28/2020
Device Model NumberKC-RUMI-30
Device Catalogue NumberKC-RUMI-30
Device Lot Number238615
Was Device Available for Evaluation? No
Date Manufacturer Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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