MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD004

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Output Problem (3005)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return for evaluation.A follow-up will be provided upon completion of the investigation.This report is a follow up to mw5110321.

Event Description

Type of procedure: laparoscopic oophorectomy description of event: "laparoscopic oophorectomy attempted using the inzii retrieval system.The laparoscopic retrieval bag failed to deploy correctly and would not open.The bag was unable to be retracted, requiring cutting of the [invalid]; additional incision was required to remove the bag from inside the patient." product is available for return.Patient status: no report of patient injury.Type of intervention: additional incision was required to remove the bag from inside the patient.

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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is a follow up to mw5110321.

Event Description

Type of procedure: laparoscopic oophorectomy.Description of event: "laparoscopic oophorectomy attempted using the inzii retrieval system.The laparoscopic retrieval bag failed to deploy correctly and would not open.The bag was unable to be retracted, requiring cutting of the [invalid]; additional incision was required to remove the bag from inside the patient." product is available for return.Patient status: no report of patient injury.Type of intervention: additional incision was required to remove the bag from inside the patient.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/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 ; 9497135675
• MDR Report Key: 14962987
• MDR Text Key: 304530179
• Report Number: 2027111-2022-00652
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773(17)241212(30)01(10)1437970
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1437970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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