MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA ARCH HANDLE

Model Number UMH750

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

End of handle kept spinning.Broken in patient.Advincula arch handle umh750 (b)(4).

Event Description

End of handle kept spinning.Broken in patient.1216677-2022-00224 advincula arch handle umh750 (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr *analysis and findings *was the complaint confirmed? yes distr.History the complaint product (sn (b)(6)) was manufactured at csi on 12/02/21 under work order (b)(4).Manuf.Record review dhr - 311134 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 2-year complaint history did show similar reported complaint condition - however, those complaints were not confirmed as the units were not returned for investigation product receipt complaint unit was returned.Vis.Eval.Visual examination of the complaint product revealed physical damage.The handle was confirmed to have been detached.The welded joint was present, but its apparent that the weld was broken.Further look into the unit revealed deep dents where the device may have been bumped.Functnl eval.Complaint product was functionally evaluated and found not to function properly.The handle was broken off.Root cause while no definitive root cause could be reliably determined, the potential cause may be that the device may be been mishandled as evidenced by the various dents across the body of the device.The complaint condition appears to be an isolated incident.Each of the individual umh750 are inspected at a 100% during incoming.During the incoming inspection, a functional test is performed to inspect another portion of the unit (unrelated to the complaint failure mode) which requires gripping onto the handle.Had the handle been detached during the time of manufacture, the unit would have been identified and isolated.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as it was determined that there is no verified trends related to this complaint condition.The product met the required release specifications per dhr review.No re-training required.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: ADVINCULA ARCH HANDLE
• Type of Device: ADVINCULA ARCH HANDLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15200220
• MDR Text Key: 305282183
• Report Number: 1216677-2022-00224
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UMH750
• Device Catalogue Number: UMH750
• Device Lot Number: -
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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