MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD001

Device Problem Material Rupture (1546)

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

Event Date 09/20/2023

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: laparoscopic appendectomy.Event description: rep was informed of a case they were not present for.In the case, the surgeon retrieved the specimen but when attempting to pull the device out, the bag fragmented and burst.The fragments of the bag were retrieved and a new device was opened to complete the case.There was no patient injury and the patient is doing fine.Product available for return.Intervention: grabbed a new inzii to complete the case.Patient status: fine.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience as the bag distal tip was cleanly cut.The clear fragment was a cleanly cut piece from the tip of the bag.Based on the condition of the returned unit and the description of the event, it is likely that a sharp instrument or object came into contact with the tissue bag, causing the bag to tear during specimen removal.

Event Description

Procedure performed: laparoscopic appendectomy event description: rep was informed of a case they were not present for.In the case, the surgeon retrieved the specimen but when attempting to pull the device out, the bag fragmented and burst.The fragments of the bag were retrieved and a new device was opened to complete the case.There was no patient injury and the patient is doing fine.Product available for return intervention: grabbed a new inzii to complete the case patient status: fine.

• Brand Name: CD001, 10MM RETRIEVAL SYSTEM, 10/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: 17967575
• MDR Text Key: 326075953
• Report Number: 2027111-2023-00642
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)260411(30)01(10)1487909
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1487909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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