MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II,BACKLOADABLE

Model Number UMH650

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Umh650 lot 29371939 blue plastic part of the handle has broken during the procedure.On (b)(6) 2022- follow-up response.Was there any additional medical attention? no medical additional attention.What procedure was the physician performing? laparoscopic hysterectomy.Did the physician perform any extra step to complete the procedure/how did physician complete the procedure/was there any fragment left in the patient? changed the uterine manipulator and consumables to new ones.No fragments remained in the patient.Was there any significant delay as result of the reported condition? 30 minutes.Rumi ii backloadable umh650 e-complaint- (b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation, x-no sample returned, x-review dhr.Analysis and findings distr.History the complaint product (sn (b)(6)) was manufactured at csi on 08/18/20 under work order (b)(4).Manuf.Record review dhr - (b)(4) was reviewed and no non-conformity, related to the complaint condition, were noted.Incoming inspect.Review incoming inspection record review not applicable to this product.Serv.Hist.Record no service history record found for this unit.Historical complaint review a review of the 2-year complaint history showed similar reported complaint conditions, where the handle broke.Product receipt the complaint product has not been returned to coopersurgical.Visual eval.Visual examination of the complaint unit was not possible as product has not been returned.Functional eval.Functional evaluation was not possible as product has not yet been returned.Root cause although the product was not returned, based on the historical complaints and prior root cause investigation, it was confirmed from tests that the failures were occurring at a level of force not likely to occur with just the articulation of the handle.Instead, it was apparent that the loads required to break the handle exist when the koh efficient (ke) is not in the proper position on the arm.When the ke is not properly positioned, it can impede in the rotation of the tip drum, introducing an undesired force on the device which can result in a broken plastic handle.The plastic handle did not undergo a recent design or material change.Should complaint unit be returned in the future, additional information will be added to complaint file.Correction and/or corrective action no further corrective action is required at this time, as the complaint condition was not confirmed.Preventative action activity coopersurgical will continue to trend this complaint condition.

Event Description

Umh650 lot (b)(6) blue plastic part of the handle has broken during the procedure.01/25/2022- follow-up response.Was there any additional medical attention? no medical additional attention.What procedure was the physician performing? laparoscopic hysterectomy.Did the physician perform any extra step to complete the procedure/how did physician complete the procedure/was there any fragment left in the patient? changed the uterine manipulator and consumables to new ones.No fragments remained in the patient.Was there any significant delay as result of the reported condition? 30 minutes.1216677-2022-00030, rumi ii backloadable umh650 e-complaint (b)(4).

Manufacturer Narrative

The additional/corrected data contained in this report does not change the outcome or findings of the product complaint investigation.

Event Description

Healthcare professional reported "blue plastic part of the handle has broken during the procedure.".

• Brand Name: RUMI II,BACKLOADABLE
• Type of Device: RUMI II,BACKLOADABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 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: 13459584
• MDR Text Key: 287667261
• Report Number: 1216677-2022-00030
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K932115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UMH650
• Device Catalogue Number: UMH650
• Device Lot Number: -
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Life Threatening; Disability; Congenital Anomaly