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

Model Number UMH650

Device Problems Fitting Problem (2183); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

The catheter guide is too wide and the guide won't hold the tubing in place so it falls out.Also the clicker on the handle will not always lock.Advincula arch handle umh750 e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.Follow up - 1 corrected data : correct product number : umh650 , correct product description : rumi ii,backloadable.

Event Description

The catheter guide is too wide and the guide won't hold the tubing in place so it falls out.Also the clicker on the handle will not always lock.1216677-2021-00215 correction rumi ii backloadable umh650 (b)(4).

Event Description

The catheter guide is too wide and the guide won't hold the tubing in place so it falls out.Also the clicker on the handle will not always lock.1216677-2021-00215 correction rumi ii backloadable umh650 (b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation x-review dhr x-inspect returned samples *analysis and findings (b)(4) *was the complaint confirmed? no distribution history the complaint product ((b)(6)) was manufactured at csi on 08/27/12 under work order (b)(4).Manufacturing record review dhr - 309393 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history 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.Product receipt the complaint unit was returned.Visual eval.Visual examination of the complaint product revealed no physical damage.Functional eval.Complaint unit was functionally evaluated and found to be working properly.A dimensional check was performed on the slot of the umh650 where the tube resides, and found them to be in tolerance to the drawing.Additionally, a tube was used to test the slot, and found that the tube was being held inside slot without issues - root cause root cause not applicable as the complaint condition was not confirmed.A complaint history review did not show any other complaints of the similar condition.The umh650 did not go any recent design change.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• 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.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12579428
• MDR Text Key: 276347878
• Report Number: 1216677-2021-00215
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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