MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD003

Device Problem Material Rupture (1546)

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

Event Date 10/04/2023

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; robotic cholecystectomy event description: [hospital] the bag ripped during specimen removal through the trocar.It is unknown if the port size was enlarged.The gallbladder spilled out of the ripped bag.It is unknown where the break occurred on the bag.The bag did not break into pieces.The surgeon was able to remove the specimen with the same bag and complete the case.No patient injury.Product is available for return intervention: the surgeon was able to remove the specimen with the same bag 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 and near the welded side 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: robotic cholecystectomy.Event description: [hospital].The bag ripped during specimen removal through the trocar.It is unknown if the port size was enlarged.The gallbladder spilled out of the ripped bag.It is unknown where the break occurred on the bag.The bag did not break into pieces.The surgeon was able to remove the specimen with the same bag and complete the case.No patient injury.Product is available for return.Intervention: the surgeon was able to remove the specimen with the same bag and complete the case.Patient status: no patient injury.

• Brand Name: CD003, 5MM 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: 17992144
• MDR Text Key: 326370219
• Report Number: 2027111-2023-00653
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)260705(30)01(10)1497013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100959
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1497013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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