MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.5CM

Model Number KC-ARCH-35

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

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

"the case was going fine, they filled up the occluder balloon when they started the colpotomy, they got half way done with the colpotomy, and then there was a rapid loss of pneumo.They could hear the gas escaping through the vagina.They had to go below 4 different times, to pack the vagina with lap sponges, to try to keep pneumo, so they could successfully complete the colpotomy." (b)(4).

Event Description

"the case was going fine, they filled up the occluder balloon when they started the colpotomy, they got half way done with the colpotomy, and then there was a rapid loss of pneumo.They could hear the gas escaping through the vagina.They had to go below 4 different times, to pack the vagina with lap sponges, to try to keep pneumo, so they could successfully complete the colpotomy." ref #: (b)(4).

Manufacturer Narrative

Reference (b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned, x-review dhr.Analysis and findings: dhr review of wo# (b)(4) for pn kc-rumi-35 shows 40 boxes were made in may 2018 at csi stafford facility.Each box contains five each of the assembled kc-rumi-30 parts each assembled with one occluder pn 23670-1.There were 2 lot (247878 & 248090) of occluder used for assembling the finished goods.Inspections/tests were performed at four levels from molding through assembly into finished parts: after each lot was molded, 100% visual inspections were done and balloon-tested for air-leaks.Qc tests of occluder lots included leak testing (8 ea) by injecting 200cc saline in each.After assembly, in-process visual inspection is performed in fg lot.Non-conforming parts are culled out including cuts in the occluder.Qc completes visual inspections with samples from assembled fg lot.The complaint unit was not returned and the complaint cannot be confirmed.Complaint mentioned that the occluder failed half way during the procedure.The occluder of the kc-rumi is tested prior the surgery to verify that the unit works accordingly.A two year complaint history record review was performed and found that there were other cases similar to the complaint reported here.During the investigation into those complaints, it was concluded that the occluder encountered a sharp object during the handling process, and when inflated, the occluders leaked in multiple places.Other investigation shows a clean cut on the occluders when inflated.With existing 100% air inflation inspection and acceptance method established in cooper surgical, stafford this would have been caught in-process and scrapped.A cut and hole in the occluder can only be caused by sharp object that pierced through the layer of silicone.Unit was not returned for investigation, the root cause cannot be determined.Should it be returned in the future, any significant information gathered during the inspection of the returned product will be added to the complaint file.Correction and/or corrective action: none: corrective action is not warranted as the device was not returned for root cause investigation.A review of the ufmea (b)(4) shows that the rpn number associated with balloon breakage is at 63, and is not subject to further review and analysis.Failure mode was not determined to be a manufacturing issue.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Type of Device: KOH-EFFICIENT,RUMI,3.5CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8515406
• MDR Text Key: 142198039
• Report Number: 1216677-2019-00046
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/08/2021
• Device Model Number: KC-ARCH-35
• Device Catalogue Number: KC-ARCH-35
• Device Lot Number: 248120
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other