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

Model Number	UMB678
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Manipulating uterus as usual and noticed metal piece protruding through side of uterus once in abdomen.Colorectal surgeon placed a few stitches in mucosal lining, colonoscopy performed, no visible perforation.Any patient injury or impact to the gamete or embryo? no medical or procedural intervention? yes 1216677-2022-00335 umb678 uterine manipulator tip b e-complaint-(b)(4).
Additional Manufacturer Narrative
Coopersurgical is currently investigating the reported conditions.
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: the complaint product was manufactured at csi on 12-oct-2022 under work order (b)(4) and sold on 21-oct-2022.Manufacturing record review: dhr-325768 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.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 was returned on 14-dec-2022.The lot number of the returned product matched the lot number reported.The unit was returned on rma # 339237.Visual evaluation: visual examination of the complaint product revealed that the metal rod had pierced the balloon and that the metal rod was bent at one end.Functional evaluation: complaint product was functionally evaluated and found not to function properly.The balloon would not inflate.Root cause: no definitive root cause for this issue could be reliably determined at this time.The marketing and sales team will continue to work with the customer to figure out a possible root cause.It would take a significant force to bend the metal rod.Correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.Coopersurgical will also continue to work with the customer.No further training required at this time.Was the complaint confirmed? yes.
Event or Problem Description
Manipulating uterus as usual and noticed metal piece protruding through side of uterus once in abdomen.Colorectal surgeon placed a few stitches in mucosal lining, colonoscopy performed, no visible perforation.Any patient injury or impact to the gamete or embryo? no medical or procedural intervention? yes.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: 16000216
• Report Number: 1216677-2022-00335
• Device Sequence Number: 20275585
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2025
• Device Model Number: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 325768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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: Required Intervention
• Patient Sex: Unknown