MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYS, 10BX; GCJ

Model Number CD001

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation.The tissue bag was attached to the actuator by the cord loop.Upon further inspection, engineering found no other non-conformances.Based on the condition of the returned unit and the customer's experience, it is likely that the tissue bag fell off when an external force was applied to the edge of the tissue bag.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: "laparoscopic left salpingo-oophorectomy".(b)(4)."during the deployment of the bag, the first retrieval bag had a loose guide bead and the prongs did not expand in order to deploy the bag properly.This happened again on the second retrieval bag opened.The third and fourth retrieval bags had issues with the prongs not expanding all the way once again.Once the bags were considered nonfunctional, the tech tried to deploy the bag on the back table away from the patient and told us it took a lot of force to finally deploy the bag properly.Two additional bags were used in order to in-service the proper deployment technique." additional information was received via email from field associate on friday 13apr2018.Information regarding bags 1,2,3, and 4."the bead components did not separate inside or outside of the cavity.The bead was simply lose.The bead was attached to the string upon discovery.The cord loop/string was not cut.The entire cord loop/string was never fully in the patient during the procedure.The bag did not fully unravel/unroll due to the metal supports not expanding.There was no attempt to unroll the bag.The metal supports were partially exposed upon deployment.The bead/tissue bag was found away from the tube.According to the scrub tech, was very difficulty to deploy so it could have been interpreted as a jam.The plunger/actuator was potentially pressed forward towards the handles, then retracted, and then re-advanced; however, from the information we gathered from the case it did not seem like the tech retracted.The was bag was still attached by the string to the plunger/actuator.The device was safely removed from the patient through the trocar.There was enough room in the body cavity for the bag to open." the first 2 bags: "the bead was not fragmented and it was still attached.The term "loose" was used because it was free to slide on the string (which could possibly have occurred due to the tech pressing down on the plunger and potentially retracting a bit without knowing).There are no pictures but the only reason why it was unable to be used was because the prongs did not fully expand causing the bag to stay closed.Bags 2 and 3: "no issues with the beads according to the tech we spoke with." type of intervention: "two additional bags were used in order to in-service the proper deployment technique." patient status: no patient injury.

• Brand Name: CD001, 10MM RETRIEVAL SYS, 10BX
• 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: 7563478
• MDR Text Key: 109895049
• Report Number: 2027111-2018-00193
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)200704(30)01(10)1300296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060051
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/04/2020
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1300296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1