MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD004

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.

Event Description

Procedure performed: urology.Event description: [facility]: report from the sales rep: during a urology da vinci case, cd004 did not make a clicking sound when pushing out the collection bag.After that, when the bag was pushed into the body, the bag fell off from the holder part of the shaft.The missing parts have been collected.The case was completed with the new one.The additional information is as follows; the metal supports was fully exposed upon deployment.There was no jamming during deployment.Rather, there was no resistance when pushing the handle out (no click-like sound was heard).The plunger/actuator push forward only once towards the handles.The device has been safely removed and recovered.The way to remove was unknown.It was confirmed that there was enough room in the body cavity for the bag to open.Used about 5 times per year.Initial investigation report the event unit was returned to us and visually inspected.The bag was found to be detached from the device.The unit will be returned to amr for further evaluation.Intervention: the case was completed with the new one.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the specimen bag falling off the metal supports.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this event have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: urology.Event description: [facility] report from the sales rep.During a urology da vinci case, cd004 did not make a clicking sound when pushing out the collection bag.After that, when the bag was pushed into the body, the bag fell off from the holder part of the shaft.The missing parts have been collected.The case was completed with the new one.The additional information is as follows; the metal supports was fully exposed upon deployment.There was no jamming during deployment.Rather, there was no resistance when pushing the handle out (no click-like sound was heard).The plunger/actuator push forward only once towards the handles.The device has been safely removed and recovered.The way to remove was unknown.It was confirmed that there was enough room in the body cavity for the bag to open.Used about 5 times per year.Initial investigation report the event unit was returned to us and visually inspected.The bag was found to be detached from the device.The unit will be returned to amr for further evaluation.Intervention: the case was completed with the new one patient status: no patient injury.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17657156
• MDR Text Key: 322379041
• Report Number: 2027111-2023-00584
• Device Sequence Number: 1
• Product Code: CGJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773(17)251023(30)01(10)1469852
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1469852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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