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

Model Number 900-151

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"he reported an incident with part 900-151 that it "exploded" during a procedure." as per phone conversation (b)(6) 2018 (b)(6) stated, "the malfunction happened during a procedure of a leep cone biopsy.A few minutes were added onto the procedure because the doctor has to go in and retrieve the pieces in the body which he did successfully.The patient was not injured.".

Manufacturer Narrative

Follow up report - initiated manufacturer's investigation, no sample returned, review dhr.Analysis and findings: the reported complaint event cannot be confirmed or verified as the affected vad sample was not be returned for analysis as of the time of this investigation.It was scheduled to be returned by 5/30/2018.However, id the sample device is returned in the future and made available for investigative root cause analysis, the complaint may be reopened and addressed as needed.A review of the lot dhr (attached) did not indicate any abnormality of the assembly or in-process testing.The two-year complaint history was also reviewed and indicated this to be the first reported incident of its type.Correction and/or corrective action: none -corrective action is not warranted at this time as the affected device was not returned for investigative analysis.The reported event will be monitored for trending.Was the complaint confirmed? no.

Event Description

"he reported an incident with part 900-151 that it "exploded" during a procedure.As per phone conversation 5/4/2018 (b)(6) stated, "the malfunction happened during a procedure of a leep cone biopsy.A few minutes were added onto the procedure because the doctor has to go in and retrieve the pieces in the body which he did successfully.The patient was not injured.".

• Brand Name: FISCHER CONE BIOP EX MED
• Type of Device: FISCHER CONE BIOP EX MED
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 7492349
• MDR Text Key: 107701713
• Report Number: 1216677-2018-00020
• 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: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: 900-151
• Device Catalogue Number: 900-151
• Device Lot Number: 225649
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention