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

Model Number CA500

Device Problem Migration (4003)

Patient Problems Fluid Discharge (2686); Insufficient Information (4580)

Event Date 09/11/2023

Event Type  Injury  

Event Description

Procedure performed: cholecystectomy.Event description: translation: incident description: when using the clip applier, the 2nd clip would not clip to the tissue.Action: new clip applier used.Patient status: ok.Information received from applied medical representative via email 27sep23: the patient has to be reoperated for his cholecystectomy.The [institution] will inform ansm soon, but didn't have time for the moment.Date of event: (b)(6) 2023.The surgeon was working on the cystic artery and the cystic duct.There were issues with both loading the clip and with the clip remaining attached to the vessel.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.Patient status: the patient has to be reoperated for his cholecystectomy.Intervention: device replacement.

Manufacturer Narrative

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

Event Description

Procedure performed: cholecystectomy.Event description: translation: incident description: when using the clip applier, the 2nd clip would not clip to the tissue.Action: new clip applier used.Patient status: ok.Information received from (b)(6) medical representative via email 27sep23: the patient has to be reoperated for his cholecystectomy.The [hospital] will inform ansm soon, but didn't have time for the moment.Date of event: 11 september 2023.The surgeon was working on the cystic artery and the cystic duct.There were issues with both loading the clip and with the clip remaining attached to the vessel.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.Information received from (b)(6) medical representative via email 9oct23: 15 days after the operation, the patient required to be reoperated because there was bile everywhere in the patient.The clips were not on the cystic artery and duct anymore.Regarding the issue loading the clip: the surgeons noticed that they activated the ca500 several times before the first clip came (they noticed that issue on different ca500 but it was the first time there was such an issue with a patient).A clip entered the jaw at this point.Regarding the issue with the clip attached on the vessel: the clip completely closed.When they finished the operation the first time, the clips were totally closed.The surgeon always put 4 clips on each artery and duct, to be more secure.The clip did not remain on the vessel, that's why there was bile into the patient, and why they had to reoperate him.Information received from (b)(6) via email 19oct23: translation: on (b)(6) 2023 on a laparoscopic cholecystectomy: when using the clip applicator, the second clip did not clips to the tissue.(b)(6) 2023: revision of a laparoscopic cholecystectomy in the or at d14 due to a superinfected subhepatic hematoma.On evacuation of the haematoma, the clips attached to the cystic duct fell off and cystic duct had fallen off, and there was a biliary leak.Drainage and lavage.Patient transferred to [hospital name redacted] for ercp and prosthesis.Patient and wife informed of type of complication and future treatment.Information received from (b)(6) medical representative via email 3nov23: the patient is fine now after been reoperated.Acute, abnormal belly pain were the symptoms experienced by the patient that led to the bile leakage being discovered.Diagnostics performed to discover the bile leakage are unknown.The surgeon located and retrieved all the clips of the initial surgery.Patient status: the patient has to be reoperated for his cholecystectomy.The patient is fine now after been reoperated.Intervention: device replacement.15 days after the operation, the patient required to be reoperated.Drainage and lavage.Patient transferred to [hospital name redacted] for ercp and prosthesis.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the event unit passed all functional testing.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.The probability and criticality of 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: CLIPS, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17852955
• MDR Text Key: 324711603
• Report Number: 2027111-2023-00615
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260419(30)01(10)1489874
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1489874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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
• Patient Outcome(s): Hospitalization