MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHER CONE BIOP EX MED

Model Number	900-151
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
E-complaint-(b)(4).Additional complaint in ref.To e-complaint-(b)(4).Report stated "we have receive a vigilance about fisher cone biopsy excisor from (b)(6) hospital 4 fisher cone biopsy excisor - medium are broken during use.The hospital kept the defective products for analysis".Fischer cone biop ex med 900-151 e-complaint-(b)(4).
Event or Problem Description
"we have receive a vigilance about fisher cone biopsy excisor from french hospital 4 fisher cone biopsy excisor - medium are broken during use." 900-151 fischer cone biop ex med (b)(4).
Additional Manufacturer Narrative
Investigation no sample returned review dhr distribution history the complaint product was purchased from geotec,inc, packaged by csi in march 2020 under work order (b)(4).Manufacturing record review dhr 287598 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-20-03-21-022 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 showed similar reported complaint conditions.Product receipt the complaint product has not been 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.Functional 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.Root cause root cause not applicable as the complaint condition was not confirmed.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.Was the complaint confirmed? no.

• Brand Name: FISCHER CONE BIOP EX MED
• Common Device Name: FISCHER CONE BIOP EX MED
• 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: 11615235
• Report Number: 1216677-2021-00037
• Device Sequence Number: 11637253
• Product Code: HGI
• UDI-Device Identifier: 00888937003710
• UDI-Public: 888937003710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061651
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 900-151
• Device Catalogue Number: 900-151
• Device Lot Number: 287598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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