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 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow-up report will be provided upon completion of investigation.This report is to follow-up medwatch #mw5117961.

Event Description

Procedure performed: event description: rep was not present for the case."bag broke while taking out specimen." there was no patient injury.Product is available for return.Additional information was received via medwatch # mw5117961 on 06jun2023: "the bottom of the endocatch bag at the seam broke while the resident was pulling the bag through the trocar site.This caused the appendix to fall back into the abdominal cavity.Another endocatch bag was used to retrieve the appendix.No injury noted." intervention: another endocatch bag was used to retrieve the appendix.Patient status: no patient injury.

Event Description

Procedure performed: laparoscopic appendectomy.Event description: rep was not present for the case."bag broke while taking out specimen." there was no patient injury".Product is available for return.Additional information was received via medwatch # mw5117961 on 06jun2023 "the bottom of the endocatch bag at the seam broke while the resident was pulling the bag through the trocar site.This caused the appendix to fall back into the abdominal cavity.Another endocatch bag was used to retrieve the appendix.No injury noted." additional information was received via email on 22jun2023 from [name], applied medical account manager: "the inzii retrieval bag broke at the bottom of the bag near the seam causing the appendix to fall back into the patients abdomen." the procedure was a laparoscopic appendectomy.Intervention: another endocatch bag was used to retrieve the appendix.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience as the bag was torn at the tip.Stretching was also observed near the tear.Based on the condition of the returned unit and the description of the event, it is likely that the incision size was not adequately enlarged prior to specimen removal, resulting in excessive force exerted on the tip of the bag and causing the bag to tear.The instructions for use (ifu) states, "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal." this report is a follow-up to medwatch #mw5117961 correction: procedure performed within section b5 has been updated to laparoscopic appendectomy based on additional information received from the user facility after the initial medwatch # 2027111-2023-00487 was submitted.

• 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: 17112665
• MDR Text Key: 317111596
• Report Number: 2027111-2023-00487
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)260118(30)01(10)1478086
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

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: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1478086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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