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

Model Number	UMB678
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report stated - plastic rumi tip broke while manipulating the uterus causing uterine preformation which was near the bowl.1216677-2021-00186 uterine manipulator tip b umb678 e-complaint-(b)(4).
Event or Problem Description
Customer stated: "plastic rumi tip broke while manipulating the uterus causing uterine performation which was near the bowl".Umb678 uterine manipulator tip b (b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples.Distribution history the complaint product was manufactured at csi in june 2021 under work order (b)(4).Manufacturing record review dhr21dsp003567 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.Product receipt the complaint product was returned.The lot number of the returned product matched the lot number reported.Visual evaluation visual examination of the complaint product revealed no physical damage.It was noticed the metal rod, which is inserted in the tip at the assembly operation, was removed from the tip.The metal rod is used to connect to the handle.Functional evaluation complaint product was functionally evaluated and found to function properly.The balloon inflated as normal.Root cause it should be noted that each tip is 100% tested during production to ensure the balloon inflates properly.Finished goods inventory for the reported lot number is depleted.As described above, it was noticed the metal rod, which is inserted in the tip at the assembly operation, was removed from the tip.The metal rod is used to connect to the handle.It is not clear if this caused the reported condition.This complaint condition is considered an isolated incident.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.Was the complaint confirmed? yes.

• Brand Name: UTERINE MANIPULATOR TIP B
• Common Device Name: UTERINE MANIPULATOR TIP B
• 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: 12563162
• Report Number: 1216677-2021-00186
• Device Sequence Number: 4460540
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K932115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 306481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown