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

Model Number	CD005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the bag on the string broke while they were pulling it out of the patient.The bag was not full.The bag popped when they were taking the gallbladder out of the patient.[name] confirmed that there was only 1 medical device malfunction.Additional information provided by [name] on 24mar2025.The bottom of the bag broke at the seal and the specimen was left in the abdominal wound.It was a 12mm port.We were able to get it out.The gallbladder had large stones.Dr.[name] was pulling forefully but not so hard that he expected the bag to break.Intervention: we were able to get it out.Patient status: the patient is fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.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 trends were identified.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the bag on the string broke while they were pulling it out of the patient.The bag was not full.The bag popped when they were taking the gallbladder out of the patient.[name] confirmed that there was only 1 medical device malfunction.Additional information provided by [name] on 24mar2025.The bottom of the bag broke at the seal and the specimen was left in the abdominal wound.It was a 12mm port.We were able to get it out.The gallbladder had large stones.Dr.[name] was pulling forefully but not so hard that he expected the bag to break.Intervention: we were able to get it out.Patient status: the patient is fine.

• 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: 21867451
• Report Number: 2027111-2025-00473
• Device Sequence Number: 4709033
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K232880
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 1538130
• Was Device Available for Evaluation?: No
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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
• Patient Sex: Unknown