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

Model Number	900-152
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
Event or Problem Description
Event description: when md first engaged electrode, there was a flash, assumed tissue, removed and saw plastic melted and smoking.No issues with patient - used another with same lot - worked ok and finished case.(b)(4).
Event or Problem Description
When md first engaged electrode, there was a flash, assumed tissue, removed and saw plastic melted and smoking.No issues with patient, used another with same lot - worked ok and finished case.1216677-2020-00119-1 fischer cone biop ex lg 900-152 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned review dhr analysis and findings distribution history the complaint product was purchased from geotec on 10/19/2019.Manufacturing record review dhr-900-152-232537 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc inspection report could not be reviewed as there was no inspection performed, part number 15006-03 top assembly part number was on dts at the time of receipt.Service history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history indicated similar reported complaint conditions.Product receipt the complaint product was not 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 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.Correction and/or corrective action coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time.No further training required at this time; complaint will be monitored for trending.Was the complaint confirmed? no.

• Brand Name: FISCHER CONE BIOP EX LG
• Common Device Name: FISCHER CONE BIOP EX LG
• 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: 10058324
• Report Number: 1216677-2020-00119
• Device Sequence Number: 14390952
• Product Code: HGI
• UDI-Device Identifier: 00888937003727
• UDI-Public: 888937003727
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/23/2023

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: 900-152
• Device Catalogue Number: 900-152
• Device Lot Number: 232537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 02/23/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown