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

Model Number	900-154
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6), inc.Is currently investigating the reported condition.
Event or Problem Description
E-complaint- (b)(4).Report stated - during leep surgery, rubber tip melted and tip broke." fischer cone biop ex m ex 900-154 e-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned review dhr distribution history the 15006-02 fisher cone assembly was purchased from geotec, inc.As an oem finished product, issued to work order 238700 as csi part number 900-154.Manufacturing record review dhr-900-154- 238700 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review a review of the incoming inspection record could not be performed as the record could not be located at the time of this investigation.If the incoming inspection record should be located going forward, it will be reviewed, and this complaint amended accordingly.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 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 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 complaint unit has not been returned to coopersurgical so the complaint could not be confirmed.Coopersurgical will continue to trend this complaint condition.No further corrective actions necessary.No further training is required since the complaint was not confirmed.Was the complaint confirmed? no.
Event or Problem Description
Customer stated: "during leep surgery, rubber tip melted and tip broke".1216677-2020-00265-1 900-154 fisher cone biop ex m exe-complaint (b)(4).

• Brand Name: FISCHER CONE BIOP EX M/EX
• Common Device Name: FISCHER CONE BIOP EX M/EX
• 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: 10853589
• Report Number: 1216677-2020-00265
• Device Sequence Number: 14266472
• Product Code: HGI
• UDI-Device Identifier: 00888937003734
• UDI-Public: 888937003734
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• 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): 02/01/2023

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: 900-154
• Device Catalogue Number: 900-154
• Device Lot Number: 238700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/01/2023
• 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