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

Model Number CD003

Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Type of procedure performed: lap cholecystectomy catch bag got stuck after specimen placed inside.String not retrievable and handle not retractable.Specimen had to be cut free of bag inside patient.No other products were damaged patient status: patient is fine, and completely unaffected.

Event Description

Type of procedure performed: lap cholecystectomy.Catch bag got stuck after specimen placed inside.String not retrievable and handle not retractable.Specimen had to be cut free of bag inside patient.No other products were damaged patient status: patient is fine, and completely unaffected type of intervention: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.The bead and a portion of the tissue bag were positioned inside of the formed tube.The bottom of the tissue bag had been cut.The event unit was disassembled and the pawl, an internal component of the device, was deformed.When the actuator was removed from the formed tube, the supports and cap were no longer attached to the event unit.Based on the event description and evaluation of the returned unit, it is likely the event was caused by a jammed cord loop, which resulted in the user cutting the tissue bag.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

• 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
• MDR Report Key: 11631150
• MDR Text Key: 246596573
• Report Number: 2027111-2021-00434
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)231001(30)01(10)1397855
• Combination Product (y/n): N
• PMA/PMN Number: K100959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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 Expiration Date: 10/01/2023
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1397855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1