MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.0 SOFT KOH-EFF

Model Number AD750SC-KE30

Device Problem Sparking (2595)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"this customer had a sparking issue on use of one of their soft cup delineator 3.0 cases".(b)(4).

Manufacturer Narrative

Reference: e-complaint (b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned, x-review dhr.Analysis and findings: the reported event cannot be verified due to the absence of the affected device at the time of this investigation.However, if the affected device is returned in the future, and made available for investigative analysis the complaint may be reopened and addressed as needed.A review of the device history record for lot no.264-18 was made under wo (b)(4) indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.It has been affirmed by the resident cmo that it is possible to have arching occur while using the device along with electrocautery devices.The evidence on the koh-efficient cup is not out of the ordinary and commonly found on other used devices and may be attributed to incorrect user technique.This device is oem manufactured for csi which sends it to another outside contractor for sterilization and distributes it from fg warehouse trumbull.All devices are is 100% inspected by the oem before being shipped to csi in trumbull, ct.Correction and/or corrective action: none.Corrective action is not warranted as this event result has been acknowledged as normal occurrence by the csi resident cmo.Per the pfmea (rmf0004-dfmea) the rpn number associated with arcing is at 54, and is not subject to further review and analysis.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"this customer had a sparking issue on use of one of their soft cup delineator 3.0 cases." ref e-complaint (b)(4).

• Brand Name: STERILE 3.0 SOFT KOH-EFF
• Type of Device: STERILE 3.0 SOFT KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8355482
• MDR Text Key: 138119895
• Report Number: 1216677-2019-00045
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/21/2021
• Device Model Number: AD750SC-KE30
• Device Catalogue Number: AD750SC-KE30
• Device Lot Number: 264-18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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