MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIPS, IMPLANTABLE

Model Number CA500

Device Problem Failure to Fire (2610)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/24/2022

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: ni.Event description: i have been informed today by [deputy team leader's name redacted] at [facility] that they have 2 x clip appliers (ca500) that are ¿faulty¿ from (b)(6) 2022.Additional information received by mhra via sharing the mir reported on 31jan23: the clip applier did not fire properly multiple times.The surgeon has difficulty putting the clip applier in and out of the 5mm port as well.The lot number is 1436503.Remedial actions taken: we have to use a [competitor device] as ligaclip is malfunctioning and cannot stop the bleeding.Clinical signs, symptoms and conditions (annex e imdrf): e0506 - hemorrhage/blood loss/bleeding.Health impact (annex f imdrf): f1908 - prolonged surgery.Additional information received by applied medical representative via email on 13feb23: it can be confirmed that if it is our lot number that is referenced then they are talking about our device.They would likely use ligaclip as a generic term for our clip applier.The only other device they have available in the hospital is the purple surgical 10mm clip applier.Patient status: no patient injury has been reported.Intervention: we have to use a [competitor device] as ligaclip is malfunctioning and cannot stop the bleeding.

Event Description

Procedure performed: ni event description: i have been informed today by [deputy team leader's name redacted] at [institution] that they have 2 x clip appliers (ca500) that are ¿faulty¿ from july 2022 additional information received by mhra via sharing the mir reported on 31jan23: the clip applier did not fire properly multiple times.The surgeon has difficulty putting the clip applier in and out of the 5mm port as well.The lot number is 1436503.Remedial actions taken: we have to use a [competitor device] as ligaclip is malfunctioning and cannot stop the bleeding.Clinical signs, symptoms and conditions (annex e imdrf): e0506 - hemorrhage/blood loss/bleeding.Health impact (annex f imdrf): f1908 - prolonged surgery additional information received by applied medical representative via email on 13feb23: it can be confirmed that if it is our lot number that is referenced then they are talking about our device.They would likely use ligaclip as a generic term for our clip applier.The only other device they have available in the hospital is the purple surgical 10mm clip applier.Patient status: bleeding, prolonged surgery intervention: we have to use a [competitor device] as ligaclip is malfunctioning and cannot stop the bleeding.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection noted damage to the distal ramp of the channel support assembly (csa).Functional testing confirmed the complainant¿s experience of the clips not firing properly by not loading properly in the jaws.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by a damaged csa distal ramp, which likely resulted from the component being caught within the jaws and was damaged when the device was inserted through the trocar or actuation of the trigger.This event was initially reported based on the description of the event.However, based on the evaluation of the event unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury as improper clip loading poses minimal risk to the patient and would likely be immediately identifiable and mitigated.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIPS, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16390342
• MDR Text Key: 309745262
• Report Number: 2027111-2023-00350
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)241201(30)01(10)1436503
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1436503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1