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

Model Number	UMH650
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currenlty investigating the reported condition.
Event or Problem Description
Per details reported on (b)(4)."after placing the rumi w/attachment in patient, the handle fell apart and the missing part had to be retrieved from patient.I am not sure when this particular handle was purchased.".
Additional Manufacturer Narrative
Investigation no sample returned review dhr.Analysis and findings distr.History the complaint product (sn (b)(6)) was manufactured at csi on 07/20/21 under work order (b)(4).Manuf.Record review dhr - 307499 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.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.While photos were submitted with the complaint, they could not be accessed.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional eval.Functional evaluation was not possible as product has not yet been returned.Root cause although the product was not returned, this complaint condition is similar to previous complaint instances.Based on these 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 coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time, as the complaint condition was not confirmed.Product was not returned for evaluation.Was the complaint confirmed? no.
Event or Problem Description
After placing the rumi w/attachment in patient, the handle fell apart and the missing part had to be retrieved from patient.Rumi ii backloadable umh650 e-complaint (b)(4).

• Brand Name: RUMI II,BACKLOADABLE
• Common Device Name: RUMI II,BACKLOADABLE
• 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: 16402625
• Report Number: 1216677-2023-00029
• Device Sequence Number: 17578300
• Product Code: LKF
• UDI-Device Identifier: 00888937015232
• UDI-Public: 888937015232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K932115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UMH650
• Device Catalogue Number: UMH650
• Device Lot Number: 30749929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Congenital Anomaly
• Patient Sex: Unknown