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

Model Number	CD005
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 has returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap chole.Event description: i was at [hospital] today working with dr [name].He had a lap chole and we had a cd005 bag break.The packaging was already thrown away so i was unable to get the lot number.The specimen was bagged and almost out of the patient then ripped at the bottom seam.The bag was deployed correctly.The bag was going to be reused for the gallbladder.He was removing this stone first.He pulled back on the introducer and then pulled the whole thing and trocar out.He then tried to work the bag through the incision but had it break.A cd001 was opened to finish removing the specimen and no issues.There was no patient harm.The specimen was a large stone the size of a golf ball hard as a rock.When the other bag was used the surgeon did extend the incision.I have the bag itself removed from the introducer.Additional information obtained from account manager on 21may2025: i attached a picture of the specimen previously.There was no spillage as it was a large stiff mass.The bag did not break into pieces, only at the seam.The bag did not burse during specimen removal through the trocar.The trocars pulled out and the bag top was followed and then worked out but ripped at the end before removal intervention: a cd001 was opened to finish removing the specimen and no issues.Patient status: there was no patient harm.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience, as the specimen bag was torn at the distal end.Based on the condition of the returned unit and the description of the event, it is likely that the incision site was not adequately enlarged prior to specimen removal, resulting in additional stress being applied to the bag.The instructions for use (ifu) states, "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal to avoid damage to the bag." applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.Correction: section h6.Device code has been updated to 4008 (material split, cut or torn).
Event or Problem Description
Procedure performed: lap chole.Event description: i was at thr southwest ft worth today working with dr [name].He had a lap chole and we had a cd005 bag break.The packaging was already thrown away so i was unable to get the lot number.The specimen was bagged and almost out of the patient then ripped at the bottom seam.The bag was deployed correctly.The bag was going to be reused for the gallbladder.He was removing this stone first.He pulled back on the introducer and then pulled the whole thing and trocar out.He then tried to work the bag through the incision but had it break.A cd001 was opened to finish removing the specimen and no issues.There was no patient harm.The specimen was a large stone the size of a golf ball hard as a rock.When the other bag was used the surgeon did extend the incision.I have the bag itself removed from the introducer.Additional information obtained from account manager on 21may2025: i attached a picture of the specimen previously.There was no spillage as it was a large stiff mass.The bag did not break into pieces, only at the seam.The bag did not burse during specimen removal through the trocar.The trocars pulled out and the bag top was followed and then worked out but ripped at the end before removal additional information obtained from phone call between [name] (clinical development) and [name] (account manager) on 23jun2025: [name] was in the case and in additional to what he put in the complaint he mentioned that based on his experience with ripstop bags, he thinks any ripstop bag would have broken under the same usage.The incision was too small for the specimen and when they switched to the cd001 they extended the incision by a lot to accommodate the size of the gallstone.Intervention: a cd001 was opened to finish removing the specimen and no issues.Patient status: there was no patient harm.

• 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: 22207356
• Report Number: 2027111-2025-00592
• Device Sequence Number: 15370654
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: 1546866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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