MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.0CM

Model Number KC-RUMI-30

Device Problem Inflation Problem (1310)

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

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complaete a follow up report will be filed.Ref: e-complaint (b)(4).

Event Description

Reference e-complaint (b)(4).Uf/importer report # (b)(4)."surgeon was placing intrauterine tip in preparation for laparoscopic hysterectomy.Surgeon attempted to fill balloon for appropriate placement but balloon failed after filling less then 30ml saline and would not inflate.Placement of manipulator failed and a new tip was used.".

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete a follow up report will be filed.Ref: e-complaint-(b)(4).Update 11/01/2017.Investigation: initiated manufacturer's investigation.Review dhr.Inspect returned samples.Analysis and findings: dhr review of wo# 204941 for pn kc-rumi-30 shows 100 boxes were made in april 2016 at csi stafford facility.Each box contains five each of the assembled kc-rumi-30 parts each assembled with one occluder pn (b)(4).There was 1 lot (203888) 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.4 occluders were failed from occluder work orders.Failed units were scrapped and replaced.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 further culled out including cuts in the occluder.Finally qc completes visual inspections with samples from assembled fg lot.In lot 203888, all samples passed qc inspections/tests, so lot was processed and released per established procedures.The returned unit was inspected and the burst occluder was confirmed to be present.The point of leak was observed and it appears to have a clean cut along the surface of the broken silicone.This may indicate that the occluder was near sharp object.With existing 100% air inflation inspection and acceptance method established in cooper surgical, stafford this would have been caught in-process and scrapped.In addition, there is no existing source of holes/ cuts identified after koh assemblies at the facility.A cut and hole in the occluder can only be caused by sharp object that pierced through the layer of silicone.A 2 year history review also shows other complaints where a leaking occluder was confirmed by a returned product.From those complaints, the occluders were found to have also encountered sharp objects.The complaint will be closed as this complaint was not determined to be a manufacturing issue.Correction and/or corrective action: per (b)(4), this complaint will be monitored for trending in that no injury was reported to end user or patient.Reason: not determined to be a manufacturing issue.Was the complaint confirmed? yes.

Event Description

Reference e-complaint-(b)(4).Uf/importer report # (b)(4)."surgeon was placing intrauterine tip in preparation for laparoscopic hysterectomy.Surgeon attempted to fill balloon for appropriate placement but balloon failed after filling less then 30ml saline and would not inflate.Placement of manipulator failed and a new tip was used.".

• Brand Name: KOH-EFFICIENT,RUMI,3.0CM
• Type of Device: KOH-EFFICIENT,RUMI,3.0CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6868809
• MDR Text Key: 86598611
• Report Number: 1216677-2017-00061
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/20/2019
• Device Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 204941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other