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

Model Number	UMB678
Health Effect - Clinical Codes	Tissue Damage (2104); Uterine Perforation (2121)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complaete a follow up report will be filed.(b)(4).
Event or Problem Description
(b)(4)."the coloured silicone tubing of the disposable uterine manipulator tip ripped off the internal metal post exposing the internal metal tip.The metal tip punctured through the uterus and bowel causing a bowel tear.The tear was repaired.".
Additional Manufacturer Narrative
Investigation.Initiated manufacturer's investigation.No sample returned.Review dhr.Inspect returned samples.Inspect stock product.Analysis and findings.The affected device sample from the reported event has not been returned to date for proper investigative analysis.However, if the affected device is returned and made available in the future for analysis, the complaint may be reopened and addressed as needed.Although not definitive due to the absence of the affected sample, the reported event may be possible if excessive lateral force was applied thus enabling the metal support rod to penetrate the rumi tip.This may occur when the rod is in an acute angle in relation to the rumi tip with excessive force lateral applied, pushing against the rumi tip wall from the inside - outward.Although not confirmed in this case that the rumi tip was improperly attached, the rumitips-dfu instructs the user on how to properly attach the rumi tip to the handle.A review of the two-year product complaint history indicated two other complaints similar in nature and was concluded the result of this incident was likely attributed to improper loading, and or excessive or improper manipulation force by the end user (refer to (b)(4)).Also, the reporting account has had three past reported complaints, citing compromised tubing and balloon that resulted in leaks, this may also be another indication of possible improper handling, and or use.A review of the lot dhr did not reveal any abnormalities, review of inventory indicated that there is no stock available for work order (b)(4).Correction and/or corrective action corrective action is not applicable as it is highly likely that this event was caused by improper use.All uterine manipulator products are 100% visually and functionally verified to be acceptable during manufacturing assembly.
Event or Problem Description
The coloured silicone tubing of the disposable uterine manipulator tip ripped off the internal metal post exposing the internal metal tip.The metal tip punctured through the uterus and bowel causing a bowel tear.The tear was repaired.Please note the sample is contaminated uterine manipulator tip b umb678 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): COOPER SURGICAL, INC; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 7148903
• Report Number: 1216677-2017-00075
• Device Sequence Number: 949108
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/09/2020
• Device Model Number: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 224934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2016
• 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