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 08/03/2022

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

Type of procedure: laparoscopic right oophorectomy.Event description: rep was not present for the case.When the surgeon was pulling the bag, with specimen inside, outside of the fascia the bag burst and the ovary fell back into the patient's abdomen.The surgeon found that there was a 10 mm hole in the bag.A 10 mm piece of the bag was found in the patient's fascia and was removed.The ovary was removed with another bag.There was no patient injury and there were no other devices being used to pull out the bag at the time of the event.The bag broke on the side.It is presumed that the port size was enlarged.No other information is available, the rep has made multiple attempts to gather information from the physician.Rep was reminded to submit complaint within one business day via telephone.Product is available for return.Patient status: no patient injury.Type of intervention: the case was completed with another bag.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, with a clear fragment.Visual inspection confirmed the complainant¿s experience as the bag was torn at the tip with stretching observed near the tear.The clear fragment was a cleanly cut piece from the tip of the bag.A clean cut was also noted in the middle of the bag.Based on the condition of the returned unit and the description of the event, it is likely that the incision size was not adequately enlarged before specimen removal, resulting in excessive force being exerted on the tip of the bag and causing it to tear.The instructions for use states, " if the bag and contents are too large to be extracted, carefully enlarge the port site for ease of bag removal.", also, it is likely that the middle and tip of the bag came in contact with a sharp instrument or object resulting in the clear fragment.

Event Description

Type of procedure: laparoscopic right oophorectomy.Event description: rep was not present for the case.When the surgeon was pulling the bag, with specimen inside, outside of the fascia the bag burst and the ovary fell back into the patient's abdomen.The surgeon found that there was a 10mm hole in the bag.A 10mm piece of the bag was found in the patient's fascia and was removed.The ovary was removed with another bag.There was no patient injury and there were no other devices being used to pull out the bag at the time of the event.The bag broke on the side.It is presumed that the port size was enlarged.No other information is available, the rep has made multiple attempts to gather information from the physician.Rep was reminded to submit complaint within one business day via telephone.Product is available for return.Patient status: no patient injury.Type of intervention: the case was completed with another bag.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15321019
• MDR Text Key: 302286256
• Report Number: 2027111-2022-00715
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)241121(30)01(10)1436283
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1436283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• 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