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

Model Number UMB678

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  Injury  

Event 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).

Manufacturer Narrative

Coopersurgical is currently investigating the reported conditions.

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 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
• Type of Device: 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
• MDR Text Key: 305681770
• Report Number: 1216677-2022-00335
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention