MAUDE Adverse Event Report: COOPERSURGICAL, INC. POTOCKY NEEDLE

Model Number 6066

Device Problem Break (1069)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

E-complaint-(b)(4).Incident details surrounding event: shaft of needle breaks away at plastic hub allowing the needle to either remain in patient or fall from tubex, before procedure.Patient- no injury occurred.Occurred before inserting into the patients cervix.Is this an isolated or ongoing event (if ongoing, please provide separate reports for each event)? two other separate events did occur.The event took place prior to a leep procedure and occurred before inserting into the patients cervix.Invoice #: (b)(4).Follow-up with account on other events mentioned.Follow-up response stated- "i cannot submit another complaint form for the "two other separate events that occurred" because they do not know the exact dates and the complaint is being made by 1 specific person only".Potocky needle -dental hu 6066 e-complaint-(b)(4).

Manufacturer Narrative

Investigation.X-review dhr x-inspect returned samples.*analysis and findings distribution history the complaint product was purchased from a supplier ((b)(4)) in february 2019.This particular lot number was packaged by csi under multiple work orders from june 2019 to may 2020.Manufacturing record review dhr's (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-19-02-26-023 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product (1 needle) was returned without a box.Since the original labeling was missing, the lot number of the returned product could not be determined but is assumed to be the lot number reported.Visual evaluation visual examination of the complaint product revealed no physical damage.It should be noted the tamperproof label seal on the tube was broken prior to inspection.Functional evaluation complaint product was functionally evaluated and found to function properly.Root cause root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

(b)(4).Incident details surrounding event shaft of needle breaks away at plastic hub allowing the needle to either remain in patient or fall from tubex, before procedure patient- no injury occurred.Occurred before inserting into the patients cervix.Is this an isolated or ongoing event (if ongoing, please provide separate reports for each event)? two other separate events did occur.Additional information: the event took place prior to a leep procedure and occurred before inserting into the patients cervix.Invoice #: (b)(4).Follow-up with account on other events mentioned.Follow-up response stated-" i cannot submit another complaint form for the "two other separate events that occurred" because they do not know the exact dates and the complaint is being made by 1 specific person only.".1216677-2021-00048 potocky needle -dental hu 6066 (b)(4).

• Brand Name: POTOCKY NEEDLE
• Type of Device: POTOCKY NEEDLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 75 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11569233
• MDR Text Key: 243728507
• Report Number: 1216677-2021-00048
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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 Model Number: 6066
• Device Catalogue Number: 6066
• Device Lot Number: 21018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other