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

Model Number 900-152

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/31/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

Medwatch received.Uf/importer report# (b)(4)."describe the event or problem: we were doing a leep procedure after procedure the surgical tech told me that the surgeon told her that he broke the string in the fischer cone biopsy excisor.Item broke in patient but instrument with string removed in its entirety.Team followed policy to ensure no retained surgical items.Planned procedure completed without complication and discharged home later that day.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working);" (b)(6) 2016: "the sex of the patient is actually female.I have contacted medsun for correction.Also, the device is not available for return.".

Event Description

Medwatch received.Ufi/importer report# 4100070000-2018-8013."describe the event or problem: we were doing a leep procedure after procedure the surgical tech told me that the surgeon told her that he broke the string in the fischer cone biopsy excisor.Item broke in patient but instrument with string removed in its entirety.Team followed policy to ensure no retained surgical items.Planned procedure completed without complication and discharged home later that day.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working);" 5/1/16: "the sex of the patient is actually female.I have contacted medsun for correction.Also, the device is not available for return.".

Manufacturer Narrative

Coopersurgial, inc is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.Reference e-complaint-2018-04-0000148.Update 5/18/18: investigation: the reported result in the event could not be confirmed as the actual sample was not returned for investigative analysis.However, if in the future the sample made available, the investigation may be reopened and addressed as needed.Review of the two-year tracked complaint history did not have any definitive trend.Previous engineering testing in trying to duplicate reported events were not successful in producing the failures as reported when recommended power settings were used.It is possible that a faulty generator or improper power output that was contra to the power setting could have been the cause for the failure.Proper output monitoring or output verification is recommended in the product device dfu).Review of the lot dhr did not reveal any abnormality.Was the complaint confirmed? no.

• Brand Name: FISCHER CONE BIOP EX LG
• Type of Device: FISCHER CONE BIOP EX LG
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• MDR Report Key: 7478257
• MDR Text Key: 107216029
• Report Number: 1216677-2018-00019
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K061651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 900-152
• Device Catalogue Number: 900-152
• Device Lot Number: 195015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR