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

Model Number AD750-KE35

Device Problem Use of Device Problem (1670)

Patient Problem Uterine Perforation (2121)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(4)."while the surgeon was manipulating and applying cephelad pressure the delineator perforated through the uterus.The product was disposed immediately due to the malignancy cells in the uterus.".

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete a follow up report will be filed.Ref: e-complaint-(b)(4).*investigation: 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.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).*correction and/or corrective action: corrective action is not warranted at this time due to the absence of the affected device for proper investigative analysis.Reason: per (b)(4), 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

Reference e-complaint-(b)(4)."while the surgeon was manipulating and applying cephalad pressure the delineator perforated through the uterus.The product was disposed immediately due to the malignancy cells in the uterus.".

• 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: 6566616
• MDR Text Key: 75323666
• Report Number: 1216677-2017-00031
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/05/2020
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 105-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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