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

Model Number CA500

Device Problems Failure to Align (2522); Mechanical Jam (2983)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic gastric sleeve.Event description: the surgeon experienced a jammed device with a tight trigger.It was hard to clamp all the way and the clip applier scissored.The surgeon did not torque the jaws on vessel or tubular structure.The clip was not closed over thick/dense tissue.It is unknown if the jaws located completely around the vessel or structure to be ligated.The surgeon did not skeletonize the tissue with the jaws.The device did not jam while on the vessel.The surgeon opened a new clip applier and experienced another tight trigger.The second device also did not jam while on the vessel.The case was completed with the second clip applier.No patient injury occurred.Products are available for return.Additional information was received via telephone on (b)(6) 2023 from [name], account manager i, applied medical on one of the clip appliers during the procedure, no clips came out when the surgeon fired the device.The rep was not present for the case.No additional information can be provided at this time.Patient status: no patient injury occurred.Intervention: the case was completed with the second clip applier.

Manufacturer Narrative

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

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Functional testing was performed on the event unit where all clips loaded properly when fired.All clips that loaded properly also closed properly, except one that closed incompletely.The event unit was disassembled, and one incompletely closed clip was found inside.However, no non-conformances were observed on the internal components.The complainant¿s experience of a jammed device and clips scissoring could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.

Event Description

Procedure performed: laparoscopic gastric sleeve event description: the surgeon experienced a jammed device with a tight trigger.It was hard to clamp all the way and the clip applier scissored.The surgeon did not torque the jaws on vessel or tubular structure.The clip was not closed over thick/dense tissue.It is unknown if the jaws located completely around the vessel or structure to be ligated.The surgeon did not skeletonize the tissue with the jaws.The device did not jam while on the vessel.The surgeon opened a new clip applier and experienced another tight trigger.The second device also did not jam while on the vessel.The case was completed with the second clip applier.No patient injury occurred.Products are available for return.Additional information was received via telephone on 05may2023 from [name], account manager i, applied medical on one of the clip appliers during the procedure, no clips came out when the surgeon fired the device.The rep was not present for the case.No additional information can be provided at this time.Patient status: no patient injury occurred.Intervention: the case was completed with the second clip applier.

• 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: 16908487
• MDR Text Key: 315095508
• Report Number: 2027111-2023-00449
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)251215(30)01(10)1474573
• 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: 06/30/2023

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: 1474573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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: ENDOPATH XCEL B15LT TROCAR