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

Model Number 900-154

Device Problems Break (1069); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6), inc.Is currently investigating the reported condition.

Event 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).

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 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
• Type of Device: 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
• MDR Text Key: 258305307
• Report Number: 1216677-2020-00265
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 00888937003734
• UDI-Public: 888937003734
• 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: 900-154
• Device Catalogue Number: 900-154
• Device Lot Number: 238700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• 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