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

Model Number	900-152
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currenlty investigating the reported condition.
Event or Problem Description
(b)(4).Report submitted by distributor on behalf of end-user as per num perioperative services : we at the (b)(6).Have had a run of fischer cone electrodes which have broken during lletz cases.This has resulted in numerous electrodes being used per case.Three (3) electrodes were used small x 2 & large x 1.The diathermy setting used were 50 coag & 40 cutting which is the usual setting.Fischer cone biop ex lg 900-152 (b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation review dhr inspect returned samples distribution history the 15006-03 fisher cone assembly was purchased from geotec, inc.As an oem finished product, received at csi 4/17/2019, issued to work order (b)(4) and completed 7/24/2019.Manufacturing record review the dhr for this unit was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review a review of the incoming inspection record was performed and no non-conformities, related to the complaint condition, were noted.Service history record service history record not applicable to this product.Historical complaint review a review of the product two-year history indicated that previous complaints related to the description of the reported event were reported.The reported event will be monitored for possible future reported event trending.Product receipt the sample was verified for the reported event and confirmed in the way of burnt wire on 2/19/2021.Visual evaluation the sample was verified and confirmed for the reported event.Functional evaluation functional evaluation is not applicable to this complaint.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 trend this complaint condition, no further corrective action is required at this time.No further training required at this time.Was the complaint confirmed? yes.
Event or Problem Description
Reported by distributor on behalf of end-user- "we have had a run of fischer cone electrodes which have broken during lletz cases.This has resulted in numerous electrodes being used per case".1216677-2020-00224-1 900-152 fischer cone biop ex lg (b)(4).

• 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: 10691342
• Report Number: 1216677-2020-00224
• Device Sequence Number: 3777309
• Product Code: HGI
• UDI-Device Identifier: 00888937003727
• UDI-Public: 888937003727
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 900-152
• Device Catalogue Number: 900-152
• Device Lot Number: 270696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 02/03/2023
• 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