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 12/01/2022

Event Type  malfunction  

Event Description

Procedure performed: robotic assisted cholecystectomy.Event description: the rep was not present for the case.The inzii was inserted through an 8mm port site.After retrieval and during removal of the gallbladder specimen, the bag broke at the distal tip, leaving specimen inside patient cavity.The surgeon extended the incision in order to retrieve the specimen by hand.There was no bag fragmentation.There was no injury and the patient is okay.Intervention: extended incision to receive specimen.Patient status: no injury.

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.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience as the bag was torn at the tip.Stretching was also observed near the tear.Based on condition of the returned unit and 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.".

Event Description

Procedure performed: robotic assisted cholecystectomy.Event description: the rep was not present for the case.The inzii was inserted through an 8mm port site.After retrieval and during removal of the gallbladder specimen, the bag broke at the distal tip, leaving specimen inside patient cavity.The surgeon extended the incision in order to retrieve the specimen by hand.There was no bag fragmentation.There was no injury and the patient is okay.Intervention: extended incision to receive specimen.Patient status: no injury.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16025312
• MDR Text Key: 308122602
• Report Number: 2027111-2022-00869
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 01/30/2023

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: 1465054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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