MAUDE Adverse Event Report: COOPERSURGICAL, INC. MKEVORKIAN-PACIFIC PUNCH

Model Number	64-675
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical is currently investigating the reported condition.
Event or Problem Description
Customer stated: "defective - cannot open to utilize"."provider needed to do a biopsy and the forcep did not open, it was jammed.Patient was not injured during the procedure".Repair tech stated "confirmed complaint: speculum locking knob stuck." reference repair order #: (b)(4).Kevorkian-pacific punch 64-675 (b)(4).
Additional Manufacturer Narrative
Investigation.Review dhr.Inspect returned samples.Distribution history the complaint product was purchased from a supplier, packaged by csi in october 2018 under work order (b)(4), and shipped in october 2019.Manufacturing record review dhr19mpg004457 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review.Iqc record (b)(4), iqc record (b)(4) and iqc record (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.These three incoming inspection records were dated just prior to the october 2018 packing date.Also, it should be noted that each instrument is functionally tested for a proper cut using simulated tissue (2 mil plastic).Service history record.This product was returned to coopersurgical service and repair department in september 2020 under repair order (b)(4).Historical complaint review.A review of the 2-year complaint history showed similar reported complaint conditions.Product receipt.This instrument was sent back as a repair item in september 2018.Visual evaluation.The returned instrument was reviewed by a service and repair technician and found in need of sharpening (reference repair order 94862).Functional evaluation.The returned instrument was sharpened.Root cause.The root cause of this issue has been attributed to normal wear from use.Corrective actions the complaint unit had the punch sharpened and was cleaned.The repaired instrument was returned to the customer.Coopersurgical will continue to trend this complaint condition.No training required at this time.Was the complaint confirmed? yes.
Event or Problem Description
Customer stated: "defective - cannot open to utilize.Provider needed to do a biopsy and the forcep did not open, it was jammed.- patient was not injured during the procedure".1216677-2020-00225-1 64-675 kevorkian-pacific punch e-complaint (b)(4).

• Brand Name: MKEVORKIAN-PACIFIC PUNCH
• Common Device Name: KEVORKIAN-PACIFIC PUNCH
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10637032
• Report Number: 1216677-2020-00225
• Device Sequence Number: 14188771
• Product Code: HFB
• UDI-Device Identifier: 00888937017489
• UDI-Public: 888937017489
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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 Model Number: 64-675
• Device Catalogue Number: 64-675
• Device Lot Number: 1580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown