MAUDE Adverse Event Report: COOPERSURGICAL INC. AD750-KE35-STERILE 3.5 ULTEM KOH-EFF

Model Number AD750-KE35

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not been returned.Once the investigation is completed a follow up report will be filed.(b)(4).Device not returned.

Event Description

"the vagina got caught under the lock groove and caused a defect wound in the vagina that required the surgeon to stitch and repair it." (b)(4).

Manufacturer Narrative

The reported complaint of the lock slipping and not being able to hold the koh in place cannot verified due to the absence of the affected sample in that it will not be returned.However, if the affected sample is returned in the future the complaint may be reopened and addressed as needed.R& d engineering has launched an investigation to evaluate similar complaints as part of a cip task.It should be noted that past returned device samples that were returned for similar reported incidents were not reproducible.Evaluation tests were performed by r&d engineering on identical devices by placing thirty (30lbs) pound weights atop the adapter drape when locked onto the tube, and could not replicate the reported events of the latch not holding; tests were performed in dry and wet states.This device is oem manufactured for csi which sends it to another outside contractor for sterilization and distributes it from (b)(4).All devices are is 100% inspected by the oem before being shipped to csi in (b)(4).A review of (b)(4) were performed and both documents addressed the reported event with proper process controls or verification(s) for clear tip attachment.

Event Description

During the case, the locking mechanism would flip up and become unlocked whenever the surgeon was pushing with cephalad pressure.She repeatedly had to re-lock the device mechanism.In a previous case when the doctor was evacuating the uterus, the lock flipped up, so the surgeon pressed the lock down.The vagina got caught under the lock groove and caused a defect wound in the vagina that required the surgeon to stitch and repair it.

• Brand Name: AD750-KE35-STERILE 3.5 ULTEM KOH-EFF
• Type of Device: STERILE 3.5 ULTEM KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5614240
• MDR Text Key: 43847135
• Report Number: 1216677-2016-00016
• Device Sequence Number: 1
• Product Code: HGI
• 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,health
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 009-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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; Required Intervention