MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 ULTEM KOH-EFF

Model Number AD750-KE35

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.

Event Description

Report submitted by csi rep- incident details- "i had two separate doctors say that the handle on the delineator broke into two pieces.I saw it myself, this occurred perioperatively and they had to take them out of the patients and insert a new delineator." ref e-complaint-(b)(4).Sterile 3-5 ultem koh-eff ad750-ke35 e-complaint-(b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation x-no sample returned.X-review dhr.Analysis and findings e-complaint (b)(4).Distribution history the complaint product was manufactured at csi on 03/06/20 under work order (b)(4).Manuf.Record review dhr - 285785 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 hist.Record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did showed similar reported complaint conditions.Of the similar reported conditions, only one was returned for a handle split, however, it is unknown if the failure mode is the same as mentioned in this complaint, as the product was not returned.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.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.However, the complaint similar to other complaints as mentioned earlier.Root cause the root cause of this issue cannot be reliably determined based on the information provided.The product was discarded and was not available for root cause analysis.However, from historical complaints review, there is a complaint that may be related and may be of similar nature.As a result of that complaint, a quality alert was created.Correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report submitted by csi rep- incident details- "i had two separate doctors say that the handle on the delineator broke into two pieces.I saw it myself, this occurred perioperatively and they had to take them out of the patients and insert a new delineator." ref e-complaint (b)(4).1216677-2020-00191 sterile 3-5 ultem koh-eff ad750-ke35 e-complaint (b)(4).

• Brand Name: STERILE 3.5 ULTEM KOH-EFF
• Type of Device: STERILE 3.5 ULTEM KOH-EFF
• 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 dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10466606
• MDR Text Key: 209030996
• Report Number: 1216677-2020-00191
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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 Expiration Date: 03/06/2023
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 285785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other