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

Model Number CA500

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: lap cholecystectomy.Event description: "the clip applier malfunctioned.Dr.[name] fired (actuated device and closed a couple of clips-we don¿t know how many) and then it would not longer reload clips into the jaws.Dr.[name] did not fire more than the total 20 clips.Applied rep (myself) was not present for the case.In order to proceed with the case, they opened another clip applier ca500 and were able to finish the case.There was no patient injury." the trigger was able to be actuated for the first few clips.No clips were loaded into the jaws prior to the device's insertion/removal through the trocar.No clips were manually removed as a loaded clip.Product is available for return.Additional information was received via email on 21feb2023 from [name], account manager i, applied medical the surgeon used a ctr03 applied kii 5x100 optical trocar."the clip properly seated in the jaws for the first few actuations but would not seat into the jaws after the first few times." additional information was received via email on 10may2023 from [name], complaint engineer i, applied medical engineering noticed a piece of the housing missing from the device on (b)(6) 2023 which could potentially change the reportability of the complaint and therefore affect the alert date.Additional information was received via email on 10may2023 from [name], account manager i, applied medical "i spoke with the staff that was present in the operating room for the case where we had to do the cer.Unfortunately, since it has been awhile, they don¿t recall how the plastic piece went missing or if it was there to begin with." patient status: there was no patient injury.Intervention: "they opened another clip applier ca500 and were able to finish the case.".

Event Description

Procedure performed: lap cholecystectomy.Event description: "the clip applier malfunctioned.Dr.[name] fired (actuated device and closed a couple of clips-we don¿t know how many) and then it would not longer reload clips into the jaws.Dr.[name] did not fire more than the total (b)(4) clips.Applied rep (myself) was not present for the case.In order to proceed with the case, they opened another clip applier ca500 and were able to finish the case.There was no patient injury." the trigger was able to be actuated for the first few clips.No clips were loaded into the jaws prior to the device's insertion/removal through the trocar.No clips were manually removed as a loaded clip.Product is available for return.Additional information was received via email on 21feb2023 from [name], (b)(6).The surgeon used a ctr03 applied kii 5x100 optical trocar."the clip properly seated in the jaws for the first few actuations but would not seat into the jaws after the first few times." additional information was received via email on 10may2023 from [name], complaint (b)(6).Engineering noticed a piece of the housing missing from the device on 27mar2023 which could potentially change the reportability of the complaint and therefore affect the alert date.Additional information was received via email on 10may2023 from [name], (b)(6)."i spoke with the staff that was present in the or for the case where we had to do the cer.Unfortunately, since it has been awhile, they don¿t recall how the plastic piece went missing or if it was there to begin with." patient status: there was no patient injury.Intervention: "they opened another clip applier ca500 and were able to finish the case.".

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection noted that the distal ramp of the channel support assembly (csa) was damaged and a piece of the housing adjacent to the distal ramp was also broken off.Functional testing confirmed the complainant¿s experience of the clips not loading properly.Based on the condition of the returned unit and the description of the event, it is likely that the reported event and component separation were caused by the damaged distal ramp of the csa, which likely resulted from the component being caught within the jaws and further damaged when the device was inserted through the trocar.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, 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: 16908459
• MDR Text Key: 315001871
• Report Number: 2027111-2023-00447
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)251116(30)01(10)1471548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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: 1471548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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
• Treatment: CTR03 APPLIED KII 5X100 OPTICAL TROCAR.