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

Model Number KC-RUMI-35

Device Problem Inflation Problem (1310)

Patient Problem Laceration(s) (1946)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigation the reported complaint condition.Once the investigation is completed a follow up report will be filed.

Event Description

The balloons inflate irregularly and as a result they've had 2 vaginal lacerations.Patient is unknown, multiple follow ups performed on (b)(6) 2016, (b)(6) 2017.Reference e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete a follow up report will be filed.(b)(4).**update 02/23/2017: investigation, x-initiated manufacturer's investigation, no sample returned, x-review dhr, ix-nspect returned samples, inspect stock product.*analysis and findings a review of the 2 yr complaint history reveals no similar issues.A dhr review of the returned unit shows that the occluder p/n 23670-1 used for the kc-rumi assembly was picked from two different lot, 203401 and 203613.A qty of (b)(4) came from occluder lot# 203401, and qty of (b)(4) from lot# 203613.The work order of both of these occluder lot shows that all products were manufactured and tested per established procedures at csi stafford facility.The complaint detail mentions that two other rumi assemblies were scrapped, with 1 pc being returned.Returned unit is unopened, and investigation was carried out with it.To recreate the issue, the assembly was inflated with water to determine the extent of the irregularity.Upon inflation of 60 cc, and subsequently to 107 cc, there were minimal signs of irregularity.The complaint cannot be confirmed based on the returned unit, as the inflation of the balloon did not show irregularities.The root cause as to why the balloon was irregular is indeterminable due to the absence of the objective evidence.A check in inventory to see if there were any more kc-rumi-35, and occluder pertaining to this lot did not show any more in stock.At this time, it is believed that this occurrence was an isolated incident, the incident will be monitored for any possible trending.*corrective actions corrective action is not applicable at this time as the root cause was indeterminable due to the absence of the affected product sample(s).All sealed and unopened product that was returned proved to work as expected.

Event Description

(b)(4).The balloons inflate irregularly and as a result they've had 2 vaginal lacerations.Patient is unknown, multiple follow ups performed on (b)(6) 2016, (b)(6) 2017.

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Type of Device: KOH-EFFICIENT,RUMI,3.5CM
• 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: 6261240
• MDR Text Key: 65518265
• Report Number: 1216677-2017-00001
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/14/2019
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 204778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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