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U.S. Department of Health and Human Services

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

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APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
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.
 
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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 Key16745372
MDR Text Key313353002
Report Number2027111-2023-00418
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K060051
Number of Events Reported1
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 NumberCD004
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 Received04/14/2023
Supplement Dates Manufacturer Received03/16/2023
Supplement Dates FDA Received07/20/2023
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 Number1
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