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 09/19/2023

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 cholecystectomy.Event description: the bag broke during the procedure.The gallbladder stones fell out of the bag and back into the patient.The surgeon opened a new bag to remove the specimen and complete the case.No patient injury.Product is available for return.Additional information was received via email on 27aug2023 from account manager ii, applied medical."i have been unsuccessful in learning the lot number for this unit or other additional info.The bag burst during specimen removal." intervention: the surgeon opened a new bag to remove the specimen and complete the case.Patient status: no patient injury.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: the bag broke during the procedure.The gallbladder stones fell out of the bag and back into the patient.The surgeon opened a new bag to remove the specimen and complete the case.No patient injury.Product is available for return.Additional information was received via email on 27aug2023 from account manager ii, applied medical "i have been unsuccessful in learning the lot number for this unit or other additional info.The bag burst during specimen removal." intervention: the surgeon opened a new bag to remove the specimen and complete the case.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.".

• 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: 17935223
• MDR Text Key: 325829437
• Report Number: 2027111-2023-00633
• Device Sequence Number: 1
• Product Code: GCJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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