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

Model Number	CD003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Procedure performed: laparoscopic salpingectomy.Event description: the cd003 was used without an applied medical 5mm trocar.The gyn fellow, dr.[name], deployed the bag through the incision.Too small of an incision and when the specimen was in the bag and the surgeon tried pulling the bag out, the bag broke.No patient injury.The case was last friday, (b)(6).I wasn't at the case and i was informed and met with the gyn coordinator and fellow.Bag wasn't kept.Surgeon and gyn coordinator said that it was a piece that is less 1mm that broke off of the bag.Additional information provided by [(b)(6)] on 24oct2025: no spillage reported to me the surgeon said that a small piece less than 1mm broke off and left in the patient.Additional information provided by [(b)(6)] on 11nov2025: just followed up with the account again this morning and the lot # is unknown.Intervention: a small piece less than 1mm broke off and left in the patient.Patient status: told by the surgeon that the patient isn't injured.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopic salpingectomy.Event description: the cd003 was used without an applied medical 5mm trocar.The gyn fellow, dr.[name], deployed the bag through the incision.Too small of an incision and when the specimen was in the bag and the surgeon tried pulling the bag out, the bag broke.No patient injury.The case was last friday, 10/17.I wasn't at the case and i was informed and met with the gyn coordinator and fellow.Bag wasn't kept.Surgeon and gyn coordinator said that it was a piece that is less 1mm that broke off of the bag.Additional information provided by [name] on 24oct2025: no spillage reported to me the surgeon said that a small piece less than 1mm broke off and left in the patient.Additional information provided by [name] on 11nov2025: just followed up with the account again this morning and the lot # is unknown.Intervention: a small piece less than 1mm broke off and left in the patient.Patient status: told by the surgeon that the patient isn't injured.

• 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: 23622566
• Report Number: 2027111-2025-00880
• Device Sequence Number: 21100379
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K100959
• 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): 04/07/2026

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: CD003
• Device Catalogue Number: 101072401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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