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

Model Number CA500

Device Problem Migration (4003)

Patient Problems Sepsis (2067); Fluid Discharge (2686)

Event Date 03/02/2023

Event Type  Death  

Manufacturer Narrative

No product is being returned to applied medical.A follow up report will be provided upon completion of the investigation.

Event Description

Procedure performed: lap chole.Event description: hospital: [name of institution].Ca500 was used in lap chole procedure.Lap chole was performed on (b)(6) 2023, ca500 was used in procedure.Patient was then readmitted to the hospital on (b)(6) 2023, was scheduled for a diagnostic lap scope, which was successfully completed on (b)(6) 2023.During the scope it was discovered that bile was leaking from the stamp, due to dislodged clip discovered in abdomen.Dr performed a abdomen washout, patient was closed and sent to icu.On (b)(6) 2023 patient was taken back to theatre for ercp.Doctor reported that the patient has passed away in the early hours of (b)(6) 2023.Situation was not resolved.Applied ports were used when the complaint event occurred.Patient status: patient is deceased.Intervention: patient was re-admitted and additional surgery was performed, dr.Performed a abdomen washout, patient was closed and sent to icu.

Event Description

Procedure performed: lap chole.Event description: hospital: [user facility].Ca500 was used in lap chole procedure.Lap chole was performed on (b)(6) 2023, ca500 was used in procedure.Patient was then readmitted to the hospital on (b)(6) 2023, was scheduled for a diagnostic lap scope, which was successfully completed on (b)(6) 2023.During the scope it was discovered that bile was leaking from the stamp, due to dislodged clip discovered in abdomen.Dr performed a abdomen washout, patient was closed and sent to icu.On (b)(6) 2023 patient was taken back to theatre for ercp.Doctor reported that the patient has passed away in the early hours of (b)(6) 2023.Situation was not resolved.Applied ports were used when the complaint event occurred.Additional information received from distributor via email 23mar23: the surgeon did not notice anything particular with the clip applier during the initial surgery.A total of six clips were used in the procedure.The clips were place in the cystic artery and duct.Clips did not fall into the abdomen during the lap chole procedure.The clip that fell into the abdomen was not retrieved.It is not available for return.The diagnostic lap scope was done due to complications of the first procedure.The complication was sepsis.Applied ports cff33,cfs12,cff03 and cfs02 were used in the procedure the clip fully loaded into the jaws upon actuation.The trigger was squeezed ¿plastic to plastic".The surgeon fully skeletonized the vessel prior to using the clip applier.The surgeon did not use the clip applier to skeletonize tissue.The clip did close.Patient status: patient is deceased.The diagnostic lap scope was done due to complications of the first procedure.The complication was sepsis.Intervention: patient was re-admitted and additional surgery was performed, dr.Performed a abdomen washout, patient was closed and sent to icu.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event of clip slippage.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the clip slippage.

• 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: 16575648
• MDR Text Key: 311616425
• Report Number: 2027111-2023-00382
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)250804(30)01(10)1461193
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1461193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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: APPLIED PORTS.; CFF03.; CFF33.; CFS02.; CFS12.
• Patient Outcome(s): Death