MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD004

Device Problem Material Rupture (1546)

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

Event Date 03/16/2023

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: thymectomy.Event description: specimen had been placed into the retrieval bag without complication.Large, solid tumour.When surgeon attempted to remove tumour through intercostal space, there was insufficient space to pass the specimen through.In an attempt to remove the tumour through the intercostal space/ribs, substantial force was required and as dr [name] was pulling the bag, it broke at the reinforced tip.Intervention: surgeon separated the ribs using a rib spreader and removed the specimen without any retrieval bag.Patient status: no patient injury, fully recovered.

Event Description

Procedure performed: thymectomy.Event description: specimen had been placed into the retrieval bag without complication.Large, solid tumour.When surgeon attempted to remove tumour through intercostal space, there was insufficient space to pass the specimen through.In an attempt to remove the tumour through the intercostal space/ribs, substantial force was required and as dr was pulling the bag, it broke at the reinforced tip.Intervention: surgeon separated the ribs using a rib spreader and removed the specimen without any retrieval bag.Patient status: no patient injury, fully recovered.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical was 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 likely that the tissue bag experienced excess stress when being pulled between the ribs and/or if the port site was not enlarged prior to removing the specimen.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." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/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: 16745372
• MDR Text Key: 313353002
• Report Number: 2027111-2023-00418
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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: CD004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 07/20/2023
• 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