MAUDE Adverse Event Report: COOPERSURGICAL, INC. 5MM ELASTIC STAYS; 5MM ELASTIC STAYS 50/CS

Model Number 3311-1G

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopsersurgical, inc.Ref: (b)(4).

Event Description

The doctor was using elastic stays with lone star 2200.After placing the hook into the tissue and was about to pull the stay back to be placed safely on the lone star locks, the stays broke.Ref: (b)(4).

Event Description

The doctor was using elastic stays with lone star 2200.After placing the hook into the tissue and was about to pull the stay back to be placed safely on the lone star locks, the stays broke.Ref: (b)(4).

Manufacturer Narrative

Investigation : x-initiated manufacturer's investigation; x-no sample returned ; x-review dhr.*nalysis and findings : distribution history; the complaint product was manufactured at csi on 11/30/18 under work order 260715.Manufctrng record review.(b)(4), was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspect review.Incoming inspection record review not applicable to this product.Service history record.Service history record not applicable to this product.Historic 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.Visual 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.The complaint condition will be verified via the pictures provided in the complaint.Functional 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.Correction and/or corrective action / *preventative action activity coopersurgical will continue to trend this complaint condition.

• Brand Name: 5MM ELASTIC STAYS
• Type of Device: 5MM ELASTIC STAYS 50/CS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct CT 06611
• MDR Report Key: 9591222
• MDR Text Key: 191402783
• Report Number: 1216677-2019-00326
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: K791665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

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
• Device Operator: No Information
• Device Model Number: 3311-1G
• Device Catalogue Number: 3311-1G
• Device Lot Number: 260715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other