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; lobectomy.Event description: when placing the specimen into the bag and during the process of removing it from the instrument, the bottom of the bag suddenly ruptured.The user only allowed us to retrieve the bag, while the remaining components were discarded.When the specimen fell from the bottom of the bag, it dropped inside the patient's body.There is no impact to patient.The user directly used other instruments to retrieve the specimen, without the need for cd001.There is no other instruments to effect this event.Product available for return additional information was received via email on 26sep2023 from [facility] the device was used in conjunction with a 12mm trocar of an unknown brand.The bag did burst during the specimens removal and to remove the specimen, the port site was enlarged.The bag did not fall off the prongs.Intervention: the user directly used other instruments to retrieve the specimen, without the need for cd001.Patient status: fine.

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.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; lobectomy.Event description: when placing the specimen into the bag and during the process of removing it from the instrument, the bottom of the bag suddenly ruptured.The user only allowed us to retrieve the bag, while the remaining components were discarded.When the specimen fell from the bottom of the bag, it dropped inside the patient's body.There is no impact to patient.The user directly used other instruments to retrieve the specimen, without the need for cd001.There is no other instruments to effect this event.Product available for return.Additional information was received via email on 26sep2023 from [facility] the device was used in conjunction with a 12mm trocar of an unknown brand.The bag did burst during the specimens removal and to remove the specimen, the port site was enlarged.The bag did not fall off the prongs.Intervention: the user directly used other instruments to retrieve the specimen, without the need for cd001.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: 17971437
• MDR Text Key: 326476295
• Report Number: 2027111-2023-00645
• 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: TW
• 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: 01/10/2024

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: 09/25/2023
• 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
• Treatment: 12MM TROCAR WITH AN UNKNOWN BRAND