MAUDE Adverse Event Report: COOPERSURGICAL, INC. CARTER-THOMASON; C-T CLOSESURE,5/BOX INLET,PN1000679

Model Number	CTI-512N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was discarded by hospital operating room.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an unknown procedure on (b)(6) 2024, the passer closure device broke in two reducing control and making a small cut in the surface of the liver.Physician coagulated the cut with a surgical cautery unit to cause hemostasis.No other issue occurred, and patient left the suite without any other complication.Device discarded by hospital.No additional information available.Cti-512n (b)(6), (b)(4).
Additional Manufacturer Narrative
Distribution history: a review of the distribution history could not be performed because the lot number provided was not valid.Should the valid complaint product lot number be provided going forward, the distribution history will be reviewed, and this complaint amended accordingly.Manufacturing record review: a review of the device history record could not be performed because the lot number provided was not valid.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the valid complaint product lot number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Historical complaint review: a review of the 2-year complaint history showed no reported complaints for this part that was broke during use.Product receipt: the complaint product has not been returned to coopersurgical as well as the lot number provided was not valid.Visual 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.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: root cause not applicable as the lot number and the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action in necessary, as the complaint condition was not confirmed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: e4: uf/importer report#: (b)(4).Additional information does not change the investigation findings.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H2: updating to include the medsun uf/importer report number in field h10 as requested.Additional information does not change the investigation findings.
Event or Problem Description
No additional information.

• Brand Name: CARTER-THOMASON
• Common Device Name: C-T CLOSESURE,5/BOX INLET,PN1000679
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 19967579
• Report Number: 1216677-2024-00041
• Device Sequence Number: 8923732
• Product Code: GCJ
• UDI-Device Identifier: 60888937000094
• UDI-Public: 60888937000094
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2024

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: Health Professional
• Device Model Number: CTI-512N
• Device Catalogue Number: CTI-512N
• Device Lot Number: 15942613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/14/2024; 11/04/2024; 11/25/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/26/2024; 11/05/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 42 YR
• Patient Sex: Female