MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD001

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The event unit is not 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: not indicated.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Two similar events occurred at the same facility.Related complaints are (b)(4).Nurse reported that 2 retrieval systems broke and they had to use a different product.No patient injury.No response from customer after 3 attempts so expect product to not return.Original email received from customer relations on (b)(6) 2023 contained information between [name] and [name] at [facility] that was not included in complaint's event description."i have a supply that the room reported the bag breaking twice." intervention: used a different product to complete the case patient status: no patient injury.

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.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

Event Description

Procedure performed: not indicated.Event description: complaint 1 of 2: 2023-001339 - mfr 2027111-2023-00670; complaint 2 of 2: 2023-001340 - mfr 2027111-2023-00673.Two similar events occurred at the same facility.Related complaints are 2023-001339 and 2023-001340.Nurse reported that 2 retrieval systems broke and they had to use a different product.No patient injury.No response from customer after 3 attempts so expect product to not return.Original email received from customer relations on 23may2023 contained information between [name] and [name] at [facility] that was not included in complaint's event description."i have a supply that the room reported the bag breaking twice." intervention: used a different product to complete the case.Patient status: no patient injury.

• 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: 18005691
• MDR Text Key: 326522895
• Report Number: 2027111-2023-00670
• Device Sequence Number: 1
• Product Code: CGJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)260208(30)01(10)1480476
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 1480476
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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