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

Model Number	CD005
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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 upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: there was a white piece of plastic that fell off inside the trocar after the bag was deployed.The team noticed it right away and was able removed it.The physician said, "i think the piece was supposed to stay at distal end but this one did not.This is a potential safety issue if it¿s not recognized before wound closure." additional information obtained from [name] via phone call on (b)(6) 2024: no intervention taken.The white retention collar was stuck in a trocar.Once they reintroduced a camera to look, the physician noticed a piece of cd005 in the trocar.It was removed from the trocar and nothing fell into the patient.All components were retrieved.No patient injury occurred.The procedure was a laparoscopic cholecystectomy.The bag functioned as normal.Intervention: it was removed from the trocar and nothing fell into the patient.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of component separation, as the bead stop subassembly was returned separately.Based on the condition of the returned unit and the description of the event, it is likely that the reduced size of the trocar, which is incompatible with the device per the instructions for use (ifu), contributed to the separation of the bead stop subassembly from the introducer.The trocar seal size was reduced to 10mm due to the use of a reducer within the trocar.However, the ifu states that the minimum port size required is 11mm.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: laparoscopic cholecystectomy.Event description: complaint 1 of 2: (b)(4) - mfr# 2027111 2024 00943.Complaint 2 of 2: (b)(4) - mfr# 2027111 2024 00966.There was a white piece of plastic that fell off inside the trocar after the bag was deployed.The team noticed it right away and was able removed it.The physician said, "i think the piece was supposed to stay at distal end but this one did not.This is a potential safety issue if it¿s not recognized before wound closure." additional information obtained from [name] via phone call on 14nov2024: no intervention taken.The white retention collar was stuck in a trocar.Once they reintroduced a camera to look, the physician noticed a piece of cd005 in the trocar.It was removed from the trocar and nothing fell into the patient.All components were retrieved.No patient injury occurred.The procedure was a laparoscopic cholecystectomy.The bag functioned as normal.Intervention: it was removed from the trocar and nothing fell into the patient.Patient status: no patient injury occurred.

• Brand Name: INZII RIPSTOP REDEPLOYABLE 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: 20861052
• Report Number: 2027111-2024-00943
• Device Sequence Number: 17112679
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K232280
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: CD005
• Device Catalogue Number: 101475688
• Device Lot Number: 1532572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: TROCAR
• Patient Sex: Unknown