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

Model Number	UMB678
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.
Event or Problem Description
Report stated "we get a call from previous client (anchor) to info us that the rumi was broken after surgery recently".04.09.2020- report update- balloon exploded when surgeon inflated with normal saline.During laparoscopic myomectomy + ovarian cystectomy + hysteroscopy.Checked for the completeness of the balloon and searched - no foreign body remained in patient body.Reference: (b)(4).Uterine manipulator tip b umb678 (b)(4).
Additional Manufacturer Narrative
Investigation.Initiated manufacturer's investigation.No sample returned.Review dhr.Distribution history the complaint product was manufactured at csi on 04/30/19 under work order 260443.Manufacturing record review dhr-umb678 - 260443 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 attached 2-year complaint history showed similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation confirmation of the reported balloon rupture event was obtained through provided attached photos.Functional 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.Root cause no definitive root cause for this issue could be reliably determined at this time.Corrective actions corrective action is not applicable at this time due to the absence of the affected sample for investigative analysis.No further training required at this time; complaint will be monitored for trending.Was the complaint confirmed? yes.
Event or Problem Description
Report stated: "balloon exploded when surgeon inflated with normal saline.During laparoscopic myomectomy + ovarian cystectomy + hysteroscopy.Checked for the completeness of the balloon and searched - no foreign body remained in patient body".1216677-2020-00095-1 umb678 uterine manipulator tip b e-complaint-(b)(4).

• 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: 9990235
• Report Number: 1216677-2020-00095
• Device Sequence Number: 2077387
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 02/06/2023

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: 260443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown