MAUDE Adverse Event Report: COOPERSURGICAL, INC. UMB678 UTERINE MANIPULATOR TIP B

Model Number UMB678

Device Problem Material Rupture (1546)

Patient Problems Perforation (2001); Unspecified Tissue Injury (4559)

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Report stated during uterine fibroid enucleatic myomectomy, the tip balloon was ruptured and the uterus was torn.The doctor thinks the tip probably had hit the uterine wall as the fibroid was enucleated and the uterus became smaller.The balloon might have been ruptured by external pressure.The uterine laceration was sutured and repaired.Uterine manipulator tip b umb678 e-complaint-(b)(4).

Manufacturer Narrative

Investigation.X-initiated manufacturer's investigation.X-no sample returned.X-review dhr.X-inspect stock product.Analysis and findings.Distribution history.The complaint product was manufactured at csi on 10/08/2021 under work order (b)(4) and sold on 11/09/2021.Manufacturing record review.Dhr-umb678-309985 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 service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history did not show similar reported complaint conditions.There were no additional instances of ruptured balloon tips causing a uterine laceration.There was one additional complaint from this lot, but it was for particulate matter and a visual defect (stain), not a functional issue.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.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.1 box (5 units, lot 318086) was pulled from current stock for testing.Using a syringe, all 5 balloons were manually inflated by with over 12 ccs of air (the maximum volume per ifu is 5) and squeezed by hand to create external pressure with no signs of rupture.The complaint condition could not be confirmed.Root cause.Root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

Event Description

Report stated "during uterine fibroid enucleatic myomectomy, the tip balloon was ruptured and the uterus was torn.The doctor thinks the tip probably had hit the uterine wall as the fibroid was enucleated and the uterus became smaller.The balloon might have been ruptured by external pressure.".The uterine laceration was sutured and repaired.1216677-2022-00093 uterine manipulator tip b umb678 e-complaint-(b)(4).

• Brand Name: UMB678 UTERINE MANIPULATOR TIP B
• Type of Device: UMB678 UTERINE MANIPULATOR TIP B
• 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 drive; trumbull, CT 06611 ; 4752551665
• MDR Report Key: 13925342
• MDR Text Key: 298209930
• Report Number: 1216677-2022-00093
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K932115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 309985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other