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

Model Number	900-151
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.
Event or Problem Description
Report submitted by csi rep.Incident detail: the doctor was using the biopsy for cautery and one side of the tip burned and cuts off.Ref (b)(4).Fischer cone biop ex med 900-151 (b)(4).
Additional Manufacturer Narrative
Investigation.Initiated manufacturer's investigation.No sample returned.Distribution history the 15006-02 fisher cone assembly was purchased from geotec, inc.As an oem finished product, issued to work order (b)(4) as csi part number 900-151 and completed 3/6/2020.Manufacturing record review dhr(b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-20-03-02-024 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 show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual 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 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 definitive root cause is indeterminable however, previous testing performed in 2011 in trying to replicate reported events of the wire "burning" or "snapping" indicated the product performed as intended, the testing was repeated in march of 2019 and resulted in the same manner.See attached copies of testing reports.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 further training required at this time.Was the complaint confirmed? no.
Event or Problem Description
"the doctor was using the biopsy for cautery and one side of the tip burned and cuts off".1216677-2020-00189-1 900-151 fischer cone biop ex med (b)(4).

• 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: 10440637
• Report Number: 1216677-2020-00189
• Device Sequence Number: 11349116
• Product Code: HGI
• UDI-Device Identifier: 00888937003710
• UDI-Public: 888937003710
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/02/2023

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: 271073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/23/2020
• Supplement Report FDA Received Date: 02/02/2023
• 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