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

Model Number 900-151

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Ref e-complaint-(b)(4).

Event Description

Per report leep procedure.(b)(6) 2020- update_"leep cone biopsy".Ref e-complaint-(b)(4).Fischer cone biop ex med 900-151 e-complaint-(b)(4).

Manufacturer Narrative

Investigation: initiated manufacturer's investigation: no sample returned: review dhr: the complaint product was purchased from geotec and packaged by csi on 01/05/18 under work order 232533.Manufacturing record review: dhr-900-151- 232533 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 showed did showed similar reported complaint conditions.Product receipt: the complaint product is unavailable for evaluation.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product is not available.If the product becomes available 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 is not available.If the product becomes available 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 (b)(6) 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.Complaint could not be confirmed, no further training required at this time.Was the complaint confirmed? no.

Event Description

Customer stated: "the electrode tip melted when in use for a leep procedure".1216677-2020-00143-1 900-151 fischer cone biop ex med (b)(4).

• Brand Name: FISCHER CONE BIOP EX MED
• Type of Device: 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: 10253486
• MDR Text Key: 203477748
• Report Number: 1216677-2020-00143
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 00888937003710
• UDI-Public: 888937003710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 900-151
• Device Catalogue Number: 900-151
• Device Lot Number: 271093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other