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

Model Number	CD001
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: gallbladder removal.Detailed description of event: the article was opened sterile in the operating room.When the sterile package was opened, a hair was found in the package.This did not guarantee sterility; the article was not usable.Additional information received from applied medical representative via email on 02jan2026: it happened not during the procedure, before use, during unpacking, on (b)(6) 2025.Event date and procedure name fields updated.Patient status: na (before use).Type of intervention: a new cd001 was used.
Event or Problem Description
Name of procedure being performed: gallbladder removal detailed description of event: the article was opened sterile in the operating room.When the sterile package was opened, a hair was found in the package.This did not guarantee sterility, the article was not usable.Additional information received from applied medical representative via email on 02jan26: photos in the attachment.It happened not during the procedure, before use, during unpacking, (b)(6) 2025.Event date and procedure name fields updated.Patient status: na (before use).Type of intervention: a new cd001 was used.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, and a photo of the event unit was provided by the complainant.Visual inspection confirmed the presence of a loose hair inside the packaging.Based on the condition of the returned unit and the description of the event, it is likely that the loose hair originated from an operator during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 24089750
• Report Number: 2027111-2026-00334
• Device Sequence Number: 17636358
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 101473283
• Device Lot Number: 1568871
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• Patient Sex: Unknown