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

Model Number CA500

Device Problem Failure to Form Staple (2579)

Patient Problem Perforation of Vessels (2135)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause of the event.Applied medical will monitor its vigilance systems for any developing trends.This report represents a combined initial and follow-up report.

Event Description

Procedure performed: laparoscopic cholecystectomy with intraoperative cholangiogram.Reps were not present for the case.Limited information is available at this time.Reps received the information 2nd hand from the materials manager.It was reported that clips failed to close on two firings on the cystic duct.The clip placed on the cystic artery scissored and severed the artery.The reps were informed that the patient status is fine.The rep will be following up with the account for additional information.It is unknown if the device is available to be returned.Additional information received via email on 12mar2020 from account mgr associate: we were able to find out a little bit more information about the incident on 3/10/2020 today while at the hospital.The original report that two clips failed to close on the cystic duct and that the 3rd clip that was fired on the cystic artery scissored and severed the artery was all accurate.The amount of bleeding can not be quantified by volume but can be described as minimal by surgeon.Below you can find more information based on your questions.The kii fios advanced fixation 5x100mm (cff03) was used with the clip applier.The artery was clamped and bleeding was minimized using laparoscopic graspers until the [name] clip was used to clip the duct and artery.The bleeding was resolved by clipping with the [name] clip applier.Not present for case but surgeon said that the tissue was larger and distal ends of clip did not fully close past the duct.The trigger was squeezed "plastic to plastic".The tip of the clip did not close.No the device is not available.Intervention: competitor device used to resolve bleeding and complete case.Patient status: fine.

• 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: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 9886658
• MDR Text Key: 185231304
• Report Number: 2027111-2020-00442
• Device Sequence Number: 1
• Product Code: FZP
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1