MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; GCJ

Model Number CD003

Device Problems Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

The event product was returned to applied medical for evaluation with the tissue bag and cord loop still attached to the introducer shaft and rod.Upon inspection, engineering noted that the deployment mechanism was deformed at the pawl tip.The tissue bag was intact and did not appear to be broken.Based on the condition of the returned unit, it is likely that the reported event was caused when the deployment mechanism was retracted prior to full deployment.This was confirmed by the damage observed on the deployment mechanism.If the device is retracted prior to full deployment, the supports may retract away from the tissue bag and cause the tissue bag to fall off the supports when deployed.Per the instructions for use (ifu), the customer should "hold the inzii retrieval system in an upright position and push the thumb ring forward to deploy and advance the rim of the bag into the body cavity.The thumb ring must be pushed completely forward until it has reached its advancing endpoint, which is indicated by a stop." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Procedure performed: total lap hysterectomy.Information was passed down to her from surgeon.The device did not work.The entire batch needs to be replaced.It is unknown the specifics of what malfunctioned.There is 1 incident device and 5 sterile units.Additional information was received via email from materials specialist ii on wednesday, (b)(6) 2018 at 11:12 am the main concern was that the bag broke.The procedure performed was a total lap hysterectomy.The event took place during the surgery.Type of intervention: received another device to complete the procedure patient status: no patient injury.

• Brand Name: CD003, 5MM RETRIEVAL SYSTEM, 10/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7559182
• MDR Text Key: 109762454
• Report Number: 2027111-2018-00187
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)210114(30)01(10)1314164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/14/2021
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1314164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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