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

Model Number KC-RUMI-35

Device Problems Melted (1385); Defective Component (2292)

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

Event Date 08/29/2019

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.Reference e-complaint (b)(4).

Event Description

Translation in english : "during an intervention on august 29th at the (b)(6), the rumi ii efficient (ref kcs-rumi-35) presented a defect related to the absence of a metal ring that generated snags by melting of the plastic on the device.This incident concerns 5 units of the same batch packaged in the same box." ref e-complaint (b)(4).

Event Description

Translation in english : "during an intervention on august 29th at the ch troyes, the rumi ii efficient (ref kcs-rumi-35) presented a defect related to the absence of a metal ring that generated snags by melting of the plastic on the device.This incident concerns 5 units of the same batch packaged in the same box." ref e-complaint-(b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation and x-review dhr.Analysis and findings: the complaint was logged to a kcs-rumi-35 with lot number 260947.Lot 260947 pertains to kc-rumi-35 and not a kcs-rumi-35.As indicated in the complaint details, the customer had ordered a kcs-rumi-35, however, a kc-rumi-35 was delivered instead.The lot number provided (260947) verifies that the product delivered was the kc-rumi-35.The customer used the kc-rumi-35 as a kcs-rumi-35 using a harmonic cutter and caused the plastic to melt.A kcs-rumi-35 has a metal ring specifically designed to be used with a harmonic scalpel and would have prevented melting of the product.Therefore, this complaint is not a manufacturing defect, as the product was not used as intended.In addition to this, there appears to have been an order fulfillment issue, as the customer had requested for a kcs-rumi-35, while a kc-rumi-35 was delivered.Dhr review of wo# (b)(4) for pn kc-rumi-35 shows 100 boxes were made in dec 2018 at csi stafford facility and there were no non-conformances.A 2 year complaint history review was performed and did not see other similar complaints pertaining to the cup melting.Correction and/or corrective action: this complaint will be monitored for trending.Not determined to be a manufacturing issue.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: KOH-EFF,RUMI,3.5CM,HARMNC
• Type of Device: KOH-EFF,RUMI,3.5CM,HARMNC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9104064
• MDR Text Key: 190543723
• Report Number: 1216677-2019-00258
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/03/2021
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 260947
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other