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

Model Number CD003

Device Problems Material Rupture (1546); Material Split, Cut or Torn (4008)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Procedure performed: robotic cholecystectomy.Event description: "bag ripped when pulling out specimen.Half of the specimen was already out.Pulled the rest through the incision site." product is available for return.Additional information was received via email on 15feb2023 from account manager, applied medical."yes, skin incision enlarged and parietal peritoneal incision enlarged.Yes, there was spillage out of the break on bag.The bag broke upon removing gallbladder specimen.Specimen was half in and half out of patient.The break occurred on the distal end of the bag tip.The bag did not break into pieces." intervention: "pulled the rest through the incision site." patient status: "nothing, specimen was half out.".

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 cholecystectomy.Event description: "bag ripped when pulling out specimen.Half of the specimen was already out.Pulled the rest through the incision site." product is available for return.Additional information was received via email on 15feb2023 from account manager, applied medical."yes, skin incision enlarged and parietal peritoneal incision enlarged.Yes, there was spillage out of the break on bag.The bag broke upon removing gallbladder specimen.Specimen was half in and half out of patient.The break occurred on the distal end of the bag tip.The bag did not break into pieces." intervention: "pulled the rest through the incision site." patient status: "nothing, specimen was half out.".

• 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: 16482858
• MDR Text Key: 310859023
• Report Number: 2027111-2023-00364
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)250718(30)01(10)1460956
• 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: 06/02/2023

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: 1460956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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