MAUDE Adverse Event Report: COOPERSURGICAL, INC. 3MM ELASTIC STAYS 8/PK; SURGICAL RETRACTOR

Model Number	3314-8G
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: uk device was discarded by hospital due to contamination.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a laparoscopic assisted pan-proctocolectomy, a lone star retractor and elastic stays were used as retraction during the procedure.When removing the device, it was noticed that one of the hooks had become detached from the surgical stay and another was bending.Therefore the retractors and stays were removed and a search of the area and patient was performed to locate the missing hook.A specimen x-ray was performed in theatre.It was established that the hook was not in the patient.3314-8g 3mm elastic stays 2024-09-0000206.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 15 may 2023.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Historic complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint product has not been returned to coopersurgical.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: no definitive root cause for this issue could be reliably determined at this time as there is no product nor pictures available for evaluation/verification.The dhr review showed that a aql sampling quality inspection pull test was performed and passed for lot 334241.No further investigation could be performed with the information available for this complaint condition.No further corrective actions required as the complaint condition was not confirmed, coopersurgical will continue to trend this complaint condition.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h11.Corrected: b1, b2, h6.The complaint investigation has not changed.Supplemental submission is to correct the codes for health impact (f) and investigation conclusion (d).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.

• Brand Name: 3MM ELASTIC STAYS 8/PK
• Common Device Name: SURGICAL RETRACTOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 20320865
• Report Number: 1216677-2024-00057
• Device Sequence Number: 20809117
• Product Code: GAD
• UDI-Device Identifier: 00888937015508
• UDI-Public: (01)00888937015508(10)334241(17)280515
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K791665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2025

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: 3314-8G
• Device Catalogue Number: 3314-8G
• Device Lot Number: 334241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 06/05/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/19/2024; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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