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

Model Number	UMW676
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2020
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 e-complaint number : (b)(4).Uterine manipulator tip w umw676 (b)(4).
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".1216677-2020-00096-1, umw676 uterine manipulator tip w e-complaint (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 03/28/19 under work order (b)(4).Manufacturing record review: (b)(4) 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 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: 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.

• Brand Name: UTERINE MANIPULATOR TIP W
• Common Device Name: UTERINE MANIPULATOR TIP W
• 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: 9993097
• Report Number: 1216677-2020-00096
• Device Sequence Number: 11282014
• Product Code: LKF
• UDI-Device Identifier: 00888937001440
• UDI-Public: 888937001440
• 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: UMW676
• Device Catalogue Number: UMW676
• Device Lot Number: 260460
• 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: 03/28/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown