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 01/25/2023

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: exploratory laparoscopic procedure.Event description: cd003 string/cord broke during retraction of the actuator.The bag was cut open in order to extract the specimen and complete the case.No patient injury occurred.Product is available for return.Intervention: the bag was cut open in order to extract the specimen and complete the case.Patient status: no patient injury occurred.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, without the bag.The cord was returned detached from the unit.Visual inspection confirmed the complainant's experience of cord damage as the cord loop was cleanly cut with a portion of it missing.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The event of cord loop damage is not reportable as it unlikely to cause or contribute to death or serious injury.This event was deemed reportable due to the bag damage that was reported as it is likely to cause or contribute to death or serious injury.

Event Description

Procedure performed: exploratory laparoscopic procedure.Event description: cd003 string/cord broke during retraction of the actuator.The bag was cut open in order to extract the specimen and complete the case.No patient injury occurred.Product is available for return.Additional information received on 24mar2023 via email from account manager: "the nurse involved did not notice the entire event." no additional information can be provided.Intervention: the bag was cut open in order to extract the specimen and complete the case.Patient status: no patient injury occurred.

• 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: 16401639
• MDR Text Key: 309988912
• Report Number: 2027111-2023-00355
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)250227(30)01(10)1443785
• 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: 04/27/2023

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: 1443785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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