MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES INZII RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CD001
Medical Device Problem Codes	Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Procedure performed: lap chole (gall bladder removal).Event description: there was a one time occurrence where dr.[name} was performing a lap chole and when pulling the bag through the 11mm port (non-applied medical trocar, possibly [competitor]) the bag ripped leaving the gallbladder in the bag falling back into the patient's body.The bag and the gallbladder that fell inside the patient were removed out of the body.The rest of the case was completed as usual.It is unknown whether another inzii bag was used to retrieve the specimen.Intervention: extracted the specimen, the rest of the case was done as usual.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of bag tear, as the specimen bag was returned torn in half.Stretching and scalloping were also observed at the tear.Based on the condition of the returned unit and the description of the event, it is likely that a sharp instrument or object came into contact with the specimen bag, initiating a tear that propagated during bag extraction.The instructions for use (ifu) states, "care should be taken to avoid contact of the bag with sharp instruments, morcellators, cutting devices, and electrosurgical and laser instruments." applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: lap chole (gall bladder removal).Event description: there was a one time occurrence where dr.[name} was performing a lap chole and when pulling the bag through the 11mm port (non-applied medical trocar, possibly [competitor]) the bag ripped leaving the gallbladder in the bag falling back into the patient's body.The bag and the gallbladder that fell inside the patient were removed out of the body.The rest of the case was completed as usual.It is unknown whether another inzii bag was used to retrieve the specimen.Intervention: extracted the specimen, the rest of the case was done as usual.Patient status: fine.

• Brand Name: INZII RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22399777
• Report Number: 2027111-2025-00627
• Device Sequence Number: 4901889
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K060051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1545952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: [COMPETITOR] CLIP APPLIER.; [COMPETITOR] TROCARS.
• Patient Sex: Unknown