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 08/20/2023

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: laparoscopic appendectomy.Event description: particles feel into the patient.All particles were retrieved.Additional information was received via email on 07sep2023 from [name], surgery buyer, [facility].No patient injury.The bag did not burst during specimen removal.There was no spillage out of the break on the bag.It is suspected that the break occurred at the distal tip.No other instruments were being used at the time of the event.The case was completed with a new bag.Additional information was received via email on 13sep2023 from [name], surgery buyer, [facility]."while obtaining specimen a piece of plastic was found that appeared to have originated from the retrieval bag.Item was suctioned and exploratory confirmation by md no foreign body retained." they do have the product the malfunctioned.Product is available for return.Intervention: all particles were retrieved.The case was completed with a new bag.Patient status: no patient injury.Discharged no issue.

Event Description

Procedure performed: laparoscopic appendectomy.Event description: particles feel into the patient.All particles were retrieved.Additional information was received via email on 07sep2023 from [name], surgery buyer, [facility] no patient injury.The bag did not burst during specimen removal.There was no spillage out of the break on the bag.It is suspected that the break occurred at the distal tip.No other instruments were being used at the time of the event.The case was completed with a new bag.Additional information was received via email on 13sep2023 from [name], surgery buyer, [facility] "while obtaining specimen a piece of plastic was found that appeared to have orginated from the retrieval bag.Item was suctioned and exploratory confirmation by md no foreign body retained." they do have the product the malfunctioned.Product is available for return.Intervention: all particles were retrieved.The case was completed with a new bag.Patient status: no patient injury.Discharged no issue.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.However, the complainant¿s experience could not be confirmed as the tissue bag was not returned with the event unit.Based on the description of the event, it is it is possible that a sharp instrument or an object came into contact with the specimen bag, causing the bag to fragment.However, the exact root cause of the bag fragmentation is unknown.

Manufacturer Narrative

Correction was made to add the patient age at time of the event within section a2 and gender within section a3 as the information received in medwatch report # (b)(4).

Event Description

Procedure performed: laparoscopic appendectomy.Event description: particles feel into the patient.All particles were retrieved.Additional information was received via email on 07sep2023 from [name], surgery buyer, [facility].No patient injury.The bag did not burst during specimen removal.There was no spillage out of the break on the bag.It is suspected that the break occurred at the distal tip.No other instruments were being used at the time of the event.The case was completed with a new bag.Additional information was received via email on 13sep2023 from [name], surgery buyer, [facility] "while obtaining specimen a piece of plastic was found that appeared to have orginated from the retrieval bag.Item was suctioned and exploratory confirmation by md no foreign body retained." they do have the product the malfunctioned.Product is available for return.Additional information received via medwatch form uf/importer report # (b)(4) on 17apr2024.Male 36 years.Intervention: all particles were retrieved.The case was completed with a new bag.Patient status: no patient injury.Discharged no issue.

• 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: 17844899
• MDR Text Key: 324607028
• Report Number: 2027111-2023-00613
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)260705(30)01(10)1497007
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 1497007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2023
• 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
• Patient Age: 36 YR
• Patient Sex: Male