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

Model Number UMH650

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

We have 2 x uhm650 which are returned back to us from customers.1 x umh650 lot 29946720: the metal rod allowing mobility of the end has broken during the procedure.01/27/2022: 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 (b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Leaking from nozzle/handle.Unable to verify complaint.Repair order: (b)(4).History: leaks at handle reported.1216677-2022-00031-1 ll100 cryosurgical 900001 e-complaint: (b)(4).

Manufacturer Narrative

Investigation: inspect returned samples.Analysis and findings: complaint: (b)(4).Distribution history: this complaint unit was manufactured at csi on 03/26/2015 under wo#: (b)(4) and shipped on 04/20/2015.Manufacturing record review: dhr-171743 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this product was returned on 12/14/2017 on repair log: (b)(4) for leaking at the brass connector, the unit was repaired and returned to the customer.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: root cause not applicable as the complaint condition was not confirmed.Corrective actions: the unit was tested per the cooper procedure and was found to be functioning correctly.The unit was returned to the customer.Cooper surgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.

• 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: 13474874
• MDR Text Key: 287799330
• Report Number: 1216677-2022-00031
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803311
• 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
• Report Date: 03/21/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Congenital Anomaly; Life Threatening; Disability