MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD004

Device Problem Material Rupture (1546)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: robotic hepatic resection: event description: two similar cd004 complaints occurred at [facility] on 21jul2023: complaint 1 of 2: (b)(4) - cd004 lot #1484721.Complaint 2 of 2: (b)(4) - cd004 lot #1484721.Today one of our surgeon was using ref#(b)(4) and two of them had a hole in the bag.Additional information was received via email on 25jul2023 from (b)(6) tissue compliance specialist,(b)(6) lot #1484721 for both items.Items were on the sterile field and discarded.Additional information will be provided regarding the case.Additional information was received via email on 28jul2023 from (b)(6) assistant nurse manager, (b)(6).The issue was noted as the specimen was being removed.The device came in contact with the patient and was removed from the robotic port.The case was completed smoothly.Photos of devices have been provided.Products are not available for return.Intervention: the case was completed smoothly.Patient status: no patient injury was reported as a result of the event.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided.Visual inspection confirmed the complainant's experience of hole in the specimen bag.Based on the description of the event and the photos provided, it is possible that a sharp instrument or an object came into contact with the specimen bag, resulting in the hole.However, the exact root cause of the specimen bag hole is unknown.

Event Description

Procedure performed: robotic hepatic resection.Event description: two similar cd004 complaints occurred at [facility] on 21jul2023: complaint 1 of 2: (b)(4) - cd004 lot #1484721 - mfr# 2027111-2023-00568.Complaint 2 of 2: (b)(4)- cd004 lot #1484721 - mfr# 2027111-2023-00567.Today one of our surgeon was using ref# cd004 and two of them had a hole in the bag.Additional information was received via email on 25jul2023 from [name], tissue compliance specialist, [facility] lot #1484721 for both items.Items were on the sterile field and discarded.Additional information will be provided regarding the case.Additional information was received via email on 28jul2023 from [name], assistant nurse manager, [facility] the issue was noted as the specimen was being removed.The device came in contact with the patient and was removed from the robotic port.The case was completed smoothly.Photos of devices have been provided.Products are not available for return.Intervention: the case was completed smoothly.Patient status: no patient injury was reported as a result of the event.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/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: 17586716
• MDR Text Key: 321684830
• Report Number: 2027111-2023-00568
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773(17)260409(30)01(10)1484721
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1484721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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: ROBOT