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 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: robotic laparoscopic cholecystectomy.Event description: the surgeon had issues with the strength of the inzii retrieval bag but noted that the functionality was good.The surgeon did not want to make the incision on the patient larger and the bag ripped at the seam during specimen removal.It is unknown if there was spillage out of the break on the bag.The specimen was the gallbladder.The bag did not break into pieces.Product is not available for return.Intervention: the surgeon used another inzii bag to complete the case.Patient status: no patient injury.

Event Description

Procedure performed: robotic laparoscopic cholecystectomy.Event description: the surgeon had issues with the strength of the inzii retrieval bag but noted that the functionality was good.The surgeon did not want to make the incision on the patient larger and the bag ripped at the seam during specimen removal.It is unknown if there was spillage out of the break on the bag.The specimen was the gallbladder.The bag did not break into pieces.No patient injury.Product is not available for return.Intervention: the surgeon used another inzii bag 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.Based on the description of the event, it is possible that the incision size was not adequately enlarged prior to specimen removal, resulting in excessive force exerted on the bag seam 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.".

• 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: 17657043
• MDR Text Key: 322378595
• Report Number: 2027111-2023-00583
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 08/30/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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