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

Model Number KCS-RUMI-30

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The actual device involved in the complaint is expected to be returned for evaluation by customer.Once the investigation is completed a follow-up will be filed.(b)(4).

Event Description

"robot assisted hysterectomy - the device has broken during the procedure, and the broken part (the cup) was stuck in the patient's vagina.Risk of perforation.The procedure has been stopped.".

Event Description

The device has broken during the procedure, and the broken part (the cup) was stuck in the patient's vagina.Risk of perforation.The procedure has been stopped.1216677-2018-00056-1 koh-eff rumi 3cm harmnc kcs-rumi-30 (b)(4).

Manufacturer Narrative

Investigation: initiated manufacturer's investigation: no sample returned.Review dhr.Analysis and findings: dhr review for product no.Kcs-rumi-30 (koh-efficient, rumi 3.0 cm), lot (b)(6) manufactured/tested during feb 2018 shows that all products were manufactured and tested per established procedures at lone star.During kcs-rumi work order, all are subjected to in-process testing to a torque test and subsequently followed by a pull test of 10 lbs, and there were no rejections observed.All assemblies met the 11-13 in-lbf torque test, and as well as 10 lbf minimum pull-force specification.Additionally, a random sample of five from the work order was inspected by qc, also subjecting the assemblies to the functional pull test of 10 lbf minimum pull force, and none were rejected.No samples were returned, so a root cause investigation was not possible.Without the unit, it is unknown how the unit broke as described in the complaint.A complaint history record review as performed no similar occurrences of complaint condition was found from the same lot.However, there were other complaints of similar condition from other work orders.The corrective action taken since was to implement a bending moment test (validated per vmp-16-0088) , testing each of the rumi assemblies at 12-13 in-lbs during in process inspection, subsequently followed by a 10 lbf functional pull test.Qc inspection involved testing 20 units sampled randomly from the work order.Correction and/or corrective action: a root cause cannot be determined for this complaint as unit was not returned for root cause investigation.Complaint incidence will be monitored and trended.Unit was not returned investigate further for any other manufacturing issues.Was the complaint confirmed? no.

• Brand Name: KOH-EFF,RUMI,3.0CM,HARMNC
• Type of Device: KOH-EFF,RUMI,3.0CM,HARMNC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 7960656
• MDR Text Key: 123674307
• Report Number: 1216677-2018-00056
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937015119
• UDI-Public: 888937015119
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2021
• Device Model Number: KCS-RUMI-30
• Device Catalogue Number: KCS-RUMI-30
• Device Lot Number: 243215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other