MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 4.0 ULTEM KOH-EFF

Model Number	AD750-KE40
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Advincula delineator broke inside of the patient.Customer said that the product "did not feel right and when it broke it caused a perforation.The clear piece that holds the handle together broke off and the handle fell apart" from rep: i spoke with the customer again yesterday and was told the perforation was in the uterus and they removed the uterus as part of the procedure.Sterile 4-0 ultem koh-eff ad750-ke40 e-complaint-(b)(4).
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
No additional information.1216677-2022-00284-1 sterile 4-0 ultem koh-eff ad750-ke40 e-complaint-(b)(4).
Additional Manufacturer Narrative
Distrib.History the complaint product was manufactured at csi on 07/18/22 under work order (b)(4).Manuf.Record review dhr - 323211 was reviewed, no nonconformities were found incoming inspection review.Incoming inspection record review not applicable to this product.Service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did show other similar reported complaint conditions.Prodct recpt.Customer returned units of the same lot number on 11/11/22, however the complaint unit was not returned.Vis.Eval.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.Out of the returned units returned, the units were inspected and found no issues with the units coming from the unopened packages.Functional eval.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the unit/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, since the product was not returned for investigation nor verification.With the information provided, a root cause analysis cannot be definitively performed.The customer returned four unopened units from the same lot number.Each of the units were inspected functionally, and were found to be in working order.The handles were inspected to try to separate the slider halves, but wasn't able to separate them as complaint had mentioned.Currently, each lot of ad750 is sampled through an established aql sample size, and is tested for slider half separation.No non-conformances were found in the lot.*correction and/or corrective action / preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: STERILE 4.0 ULTEM KOH-EFF
• Common Device Name: STERILE 4.0 ULTEM KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651665
• MDR Report Key: 15658083
• Report Number: 1216677-2022-00284
• Device Sequence Number: 15063998
• Product Code: HEW
• UDI-Device Identifier: 00888937012767
• UDI-Public: (01)00888937012767
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 09/07/2023

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: AD750-KE40
• Device Catalogue Number: AD750-KE40
• Device Lot Number: 323211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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: Other
• Patient Sex: Unknown