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

Model Number KC-RUMI-30

Device Problem Break (1069)

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

Event Date 08/06/2019

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

"item broke when inserted into patient." (b)(4).

Manufacturer Narrative

Reference e-complaint - (b)(4).Investigation: x-review dhr: x-inspect returned samples.Analysis and findings: dhr review of wo# (b)(4) for pn kc-rumi-30 shows 120 boxes were made in aug 2018 at csi stafford facility and there were no non-conformances.The complaint unit arrived via rma 298820 and was inspected.Upon inspection, the cup was confirmed to have detached from the hinge.The complaint states that the device broke while being inserted into the patient, however, it is unknown if the customer used a sizer (kcp) to determine the proper size koh-efficient to use.This is listed under the ifu of the product (rumiiikoh-dfu).The customer was reached for additional information on the procedure and how the device may have been used, however, no information was provided.With the information provided, a root cause analysis cannot be definitively performed.As a way of improving the manufacturing process, csi stafford has implemented 100% in process inspection of the product via bend testing and pull testing, followed by an aql qc inspection requiring the that the units also pass a bend and pull test.A 2 year complaint history review was performed and did not have any trend for the reported complaint condition.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for any trends.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"item broke when inserted into patient." ref e-complaint - (b)(4).

• 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 Key: 8884434
• MDR Text Key: 154392788
• Report Number: 1216677-2019-00225
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/29/2021
• Device Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 261331
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other