MAUDE Adverse Event Report: COOPERSURGICAL, INC. 5MM ELASTIC STAYS 8/PK

Model Number	3311-8G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Distributor reported on behalf of healthcare professional the product "were kept intact when removed from the package.However, during the surgery, the elastic stays are broken," and further, "when the elastic stay was being used in the surgery, it broken suddenly and so the nurse was scratched by the hook." additionally, healthcare professional reported "hook scratched through the glove and the nurse's hand during the operation, so the nurse needs to clean the wound immediately." event has resolved.
Additional Manufacturer Narrative
Clarification to component code: complaint is against the elastic part of the surgical stay.Investigation: distribution history.The complaint product was manufactured at csi on 11/07/18.Manufact.Record review device history record was reviewed and no non-conformities related to the complaint condition were noted.History complaint review a review of the 2-year complaint history showed similar reported complaint conditions.Previous complaints of stays breaking in the field were logged, but in those complaints, the stays broke due to usage, and not due to a manufacturing issue.Product receipt: the complaint product was not 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.Complaint verified based on provided pictures.Functionl evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, the complaint condition is very similar to other complaints as mentioned earlier.In those complaints, the returned stays were inspected and tested, and the stays were able to stretch without issue, indicating that there were no issues with degradation of the silicone.In addition, when those returned stays were inspected under microscope, the cuts seems to have been initiated with a clean cut, possibly due to the stays encountering a sharp object.Root cause: no definitive root cause for this issue could could be reliably determined at this time.It is possible that the silicone stay may have encountered a sharp object.Corrective action: coopersurgical will continue to trend this complaint condition.
Additional Manufacturer Narrative
Distrib.History the complaint product was manufactured at csi on 11/07/18 under work order (b)(4).Manufact.Record review dhr - 260067 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.History complaint review a review of the 2-year complaint history showed similar reported complaint conditions.Previous complaints of stays breaking in the field were logged, but in those complaints, the stays broke due to usage, and not due to a manufacturing issue.Product receipt the complaint product has not been returned to coopersurgical.There is currently no rma for the product.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.Complaint verified based on provided pictures.Functionl eval.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, the complaint condition is very similar to other complaints as mentioned earlier.In those complaints, the returned stays were inspected and tested, and the stays were able to stretch without issue, indicating that there were no issues with degradation of the silicone.In addition, when those returned stays were inspected under microscope, the cuts seems to have been initiated with a clean cut, possibly due to the stays encountering a sharp object.Root cause no definitive root cause for this issue could be reliably determined at this time.It is possible that the silicone stay may have encountered a sharp object.
Event or Problem Description
Customers reported that the elastic stays (#3311-8g) were kept intact when removed from the package.However, when the elastic stay was being used in the surgery, it broken suddenly and so the nurse was scratched by the hook.Follow up information: 1.Was the scratched deep needing any immediate medical attention? yes.The hook scratched through the glove and the nurse's hand during the operation, so the nurse needs to clean the wound immediately 2.Was the scratch surface deep no blood? it's about 3-4mm length and 1-2mm depth 3.How is the nurse/scratch now.? she is recovered already.5mm elastic stays 8-pk 3311-8g e-complaint (b)(4).

• Brand Name: 5MM ELASTIC STAYS 8/PK
• Common Device Name: 5MM ELASTIC STAYS 8/PK
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPER SURGICAL, INC; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16527072
• Report Number: 1216677-2019-00311
• Device Sequence Number: 12077044
• Product Code: GAD
• UDI-Device Identifier: 00888937015485
• UDI-Public: 888937015485
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Expiration Date: 11/07/2023
• Device Model Number: 3311-8G
• Device Catalogue Number: 3311-8G
• Device Lot Number: 260067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female