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

Model Number CD003

Device Problem Material Rupture (1546)

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

Event Date 03/10/2023

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 ovarian cystectomy.Event description: two complaints occurred at the same account on the same day in separate cases: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).The inzii bag burst when the surgeon was pulling it out from the incision site.The port size was not enlarged.There was spillage out of the break on the bag.The specimen was an ovary.The break occurred at the bottom of the bag.The bag broke into pieces and all fragments were retrieved from the patient.The case was completed with the new device.No patient injury occurred in both cases.Only one inzii is available for return.Product is available for return.Intervention: the case was completed with the new device.Patient status: "stable.".

Event Description

Procedure performed: laparoscopic ovarian cystectomy event description: two complaints occurred at the same account on the same day in separate cases: complaint 1 of 2: (b)(6) mfr# 2027111-2023-00414.Complaint 2 of 2: - (b)(6) mfr# 2027111-2023-00415.The inzii bag burst when the surgeon was pulling it out from the incision site.The port size was not enlarged.There was spillage out of the break on the bag.The specimen was an ovary.The break occurred at the bottom of the bag.The bag broke into pieces and all fragments were retrieved from the patient.The case was completed with the new device.No patient injury occurred in both cases.Only one inzii is available for return.Product is available for return.Intervention: the case was completed with the new device.Patient status: "stable.".

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 likely that the incision size was not adequately enlarged prior to specimen removal, resulting in excessive force being exerted on the tip of the bag and causing the bag to tear.The instructions for use (ifu) states, "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal." it is also possible that a sharp instrument or object came in contact with the tissue bag, causing the bag to fragment during specimen removal.

• 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: 16719636
• MDR Text Key: 313635429
• Report Number: 2027111-2023-00414
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)241130(30)01(10)1437598
• 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: 07/27/2023

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: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1437598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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