MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI ARCH,CE UTR.MAN.HNDL

Model Number UMH700

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Update: 08/06/2021- all three follow-up attempts for product details yielded no response.The reported conditon is currenlty being investigated.

Event Description

Incident report.We received the following pearl (our safety followup program) for a koh ring failure.After completion of robotic supracervical hysterectomy, rumi arch instrument with koh arch ring was removed by a surgical tech student from the patient's vagina and placed on table.Second surgeon then began robotic sacrocolpopexy and requested that new rumi arch instrument with sacrocolpopexy tip be inserted into vagina.Sacrocolpopexy tip would not center itself in vagina and appeared to deflect to the right or left when attempted.Surgeon scrubbed in to perform vaginal exam and found plastic koh ring in vagina.This piece normally is attached to the koh handle as one piece.Surgeon then resumed robotic surgery, but visually there still seemed to be a bulge of something soft within the vagina.Second vaginal exam by surgeon found a second piece of the koh arch, the fluid-filled balloon, was also still in the vagina.After removal of second piece surgeon resumed sacrocolpopexy surgery.(b)(4).

Manufacturer Narrative

Investigation initiated manufacturer's investigation no sample returned.Distribution history a distribution history record review was not possible for this product as the product type nor a lot number was provided for investigation.The complaint mentions a kc-arch (which is used in conjunction with the umh750), however it is unknown that size is mentioned.Manufacturing record review a dhr review was not possible as a lot number was not provided.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation, nor information such as the product size or lot number was provided.However, from the complaint information, the root cause of the complaint can be attributed to the improper usage of the product.The arch koh-efficient dfu (archkohadv-dfu) mentions that "once colpotomy is complete, deflate the colpo-pneumo occluder (balloon) prior to removing the system".In this case, it appears that the balloon was not deflated prior to the system removal, indicating that the complaint condition was due to usage error.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.Based on the information provided, the complaint condition was not attributed to a manufacturing defect.No further training required at this time.Was the complaint confirmed? no.

Event Description

Customer stated: "after completion of robotic supracervical hysterectomy, rumi arch instrument with koh arch ring was removed by a surgical tech student from the patient's vagina and placed on table.Second surgeon then began robotic sacrocolpopexy and requested that new rumi arch instrument with sacrocolpopexy tip be inserted into vagina.Sacrocolpopexy tip would not center itself in vagina and appeared to deflect to the right or left when attempted.Surgeon scrubbed in to perform vaginal exam and found plastic koh ring in vagina.This piece normally is attached to the koh handle as one piece.Surgeon then resumed robotic surgery, but visually there still seemed to be a bulge of something soft within the vagina.Second vaginal exam by surgeon found a second piece of the koh arch, the fluid-filled balloon, was also still in the vagina.After removal of second piece surgeon resumed sacrocolpopexy surgery." umh700 rumi arch ce utr man hndl (b)(4).

• Brand Name: RUMI ARCH,CE UTR.MAN.HNDL
• Type of Device: RUMI ARCH,CE UTR.MAN.HNDL
• 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: 12333586
• MDR Text Key: 268444241
• Report Number: 1216677-2021-00166
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DISCONTINUED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

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
• Device Operator: Health Professional
• Device Model Number: UMH700
• Device Catalogue Number: UMH700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 01/31/2023
• 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): Required Intervention; Other