MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES SOFT/FIBRA® SPRING CLIP; CLIP, VASCULAR

Model Number	G-6050
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure: kidney transplant event description: [hospital name] model #: g-6050, lot #: 1533455.Summary: during the case, the attending physician decided to "backfill" the transplanted kidney.In order to perform this, they used a spring clip, which was passed to the attending on a spring clip loader.The spring clip was successfully placed on the patient's kidney, and then the attending used papaverine, a medication, in addition.After this was used, the spring clip was removed, at which time the device broke into two separate pieces.The device was sequestered, and then passed off the field.The lot number for the device is as follows: 1533455.This lot number and expiration date were confirmed to match both spring clips which were opened for the case.Additional information provided on 17feb2025 no intervention was used to complete the procedure when the device malfunctioned.The device failed at the end of the case.No, the surgeon did not experience loss of occlusion due to jaw separation.The separation happened during the planned unclamping.There was no damage to the vessel.There was no rust noted after the device separated.Patient status: no harm intervention: ni.
Additional Manufacturer Narrative
The event unit has been returned to applied medical.A follow up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: kidney transplant.Event description: (b)(6).Summary: during the case, the attending physician decided to "backfill" the transplanted kidney.In order to perform this, they used a spring clip, which was passed to the attending on a spring clip loader.The spring clip was successfully placed on the patient's kidney, and then the attending used, a medication, in addition.After this was used, the spring clip was removed, at which time the device broke into two separate pieces.The device was sequestered, and then passed off the field.The lot number for the device is as follows: 1533455.This lot number and expiration date were confirmed to match both spring clips which were opened for the case.Additional information: no intervention was used to complete the procedure when the device malfunctioned.The device failed at the end of the case.No, the surgeon did not experience loss of occlusion due to jaw separation.The separation happened during the planned unclamping.There was no damage to the vessel.There was no rust noted after the device separated.Intervention: ni.Patient status: no harm.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.Visual inspection confirmed that the clip broke as the unit was returned with one of the jaws separated from the unit.Based on the condition of the returned unit, it is possible that the reported event was caused by the worn rib which could have occurred during manufacturing or during use.However, the exact root cause and timing could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.Based upon the initial description of the event, the event was not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable for the clip breaking and failing during use.

• Brand Name: SOFT/FIBRA® SPRING CLIP
• Common Device Name: CLIP, VASCULAR
• 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: 22287101
• Report Number: 2027111-2025-00596
• Device Sequence Number: 8929656
• Product Code: DSS
• UDI-Device Identifier: 00607915118013
• UDI-Public: (01)00607915118013
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K883909
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G-6050
• Device Catalogue Number: 101373501
• Device Lot Number: 1533455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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