MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 ULTEM KOH-EFF

Model Number AD750-KE35

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(4).Fda report mw5068804."the coopersurgical uterine delineator/manipulator has had 3 events where sparking traveling from the blue ring to the center of the manipulator tip has occurred and witnessed by the surgical staff.The manipulator itself does not connect to any sort of cautery, but only serves as a tool to move the uterus for the case and, by design, as a guide to cut the uterus and cervix away from the top of the vagina.No harm to any patients.".

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete a follow up report will be filed.(b)(4).Initiated manufacturer's investigation.No sample returned.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.It has been affirmed by the resident cmo that it is possible to have arching occur while using the device along with electro-cautery devices, and substantial fluids are present.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 (b)(4).All devices are is 100% inspected by the oem before being shipped to csi in (b)(4), the lot inspection record is attached.Correction and/or corrective action: corrective action is not warranted as this event result has been acknowledged as a normal occurrence by the csi resident cmo.Reason: per bsr-qar-026, this complaint will be monitored for trending in that no injury was reported to end user or patient.*was the complaint confirmed? no.

Event Description

(b)(4).Fda report mw5068804 "the coopersurgical uterine delineator/manipulator has had 3 events where sparking traveling from the blue ring to the center of the manipulator tip has occurred and witnessed by the surgical staff.The manipulator itself does not connect to any sort of cautery, but only serves as a tool to move the uterus for the case and, by design, as a guide to cut the uterus and cervix away from the top of the vagina.No harm to any patients.".

• Brand Name: STERILE 3.5 ULTEM KOH-EFF
• Type of Device: STERILE 3.5 ULTEM KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6555091
• MDR Text Key: 74896609
• Report Number: 1216677-2017-00027
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2017
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 182-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other