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

Model Number CD003

Device Problem Premature Separation (4045)

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

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: "robotic assisted gyn oncologist procedure".Event description: "a few weeks ago during a robotic assisted gyn oncologist procedure while using a cd003 the retrieval bag slipped completely off the metal supports." rep was not present for the case.Product is not available for return.Additional information was received via email on 14sep2023 from account manager iv, applied medical.The event occurred within the last month.The rep was made aware 13sep2023.The tip of the supports were exposed inside the patient because the bag fell off them.The bag fell down the supports during specimen insertion.There was no issue with the patient.Patient was not harmed during the issue.The case was completed by removing the bag without being fully closed upon removal.Intervention: the case was completed by removing the bag without being fully closed upon removal.Patient status: there was no issue with the patient.Patient was not harmed during the issue.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event and similar events, it is possible that the reported event was caused by a large distal force exerted on the bag, resulting in the bag falling off the metal supports.

Event Description

Procedure performed: "robotic assisted gyn oncologist procedure".Event description: "a few weeks ago during a robotic assisted gyn oncologist procedure while using a cd003 the retrieval bag slipped completely off the metal supports." rep was not present for the case.Product is not available for return.Additional information was received via email on 14sep2023 from account manager iv, applied medical the event occurred within the last month.The rep was made aware 13sep2023.The tip of the supports were exposed inside the patient because the bag fell off them.The bag fell down the supports during specimen insertion.There was no issue with the patient.Patient was not harmed during the issue.The case was completed by removing the bag without being fully closed upon removal.Intervention: the case was completed by removing the bag without being fully closed upon removal.Patient status: there was no issue with the patient.Patient was not harmed during the issue.

• 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: 17932974
• MDR Text Key: 325829594
• Report Number: 2027111-2023-00632
• Device Sequence Number: 1
• Product Code: CGJ
• 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: 12/04/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ROBOTIC INSTRUMENTS