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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap cholecystectomy.Ca500 opened in a sterile manner.Ca500 passed over to surgeon by (scrub nurse).Clip 1: pre loaded then placed over cystic artery.This clip did not move.Plastic to plastic application.Clip 2: pre loaded then placed over cystic artery.This clip migrated along the vessel and removed by surgeon with grasper.Plastic to plastic application.Clip 3: pre loaded then placed over cystic artery.As surgeon removed clip applier jaws off the vessel, the clip moved toward the jaws, was semi on vessel so surgeon removed fully.Clip 4: pre loaded then placed over cystic artery.This clip was not applied plastic to plastic and a cholangiogram clip was formed.Clip was removed from vessel.Surgeon confirmed that this clip was as a result of an accidental cholangiogram zone closure.Clip 5: pre loaded then placed over cystic artery.Clip did not move.Clips 6: loaded and dispensed outside the abdomen.Clip disposed of.Clip 7: pre loaded then placed over cystic artery.When surgeon probed the clip with grasper, it slipped off.This clip was removed from abdomen.Surgeon completed the procedure with a competitor device.Additional information received via email from representative, 28june: surgeon did not use clip applier to skeletonise the vessel.I am unsure where the vessel was fully skeletonised prior to the clips being applied.I am planning to see dr week beginning on (b)(6) to discuss this.Patient status: no injury occured.

Manufacturer Narrative

Investigation summary: the event unit was not returned to applied medical for evaluation.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 will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Procedure performed: lap cholecystectomy ca500 opened in a sterile manner.Ca500 passed over to surgeon by (scrub nurse) clip 1: pre loaded then placed over cystic artery this clip did not move.Plastic to plastic application.Clip 2: pre loaded then placed over cystic artery this clip migrated along the vessel and removed by surgeon with grasper.Plastic to plastic application: clip 3: pre loaded then placed over cystic artery.As surgeon removed clip applier jaws off the vessel, the clip moved toward the jaws, was semi on vessel so surgeon removed fully.Clip 4: pre loaded then placed over cystic artery.This clip was not applied plastic to plastic and a cholangiogram clip was formed.Clip was removed from vessel.Surgeon confirmed that this clip was as a result of an accidental cholangiogram zone closure.Clip 5: pre loaded then placed over cystic artery.Clip did not move.Clips 6: loaded and dispensed outside the abdomen.Clip disposed of.Clip 7: pre loaded then placed over cystic artery.When surgeon probed the clip with grasper, it slipped off.This clip was removed from abdomen.Surgeon completed the procedure with a competitor device.Additional information received via email from representative, 28june: surgeon did not use clip applier to skeletonise the vessel.I am unsure where the vessel was fully skeletonised prior to the clips being applied.Patient status: no injury occurred.

• 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
• MDR Report Key: 8781632
• MDR Text Key: 177942919
• Report Number: 2027111-2019-00509
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220225(30)01(10)1349057
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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 Expiration Date: 02/25/2022
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1349057
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 08/27/2019
• Patient Sequence Number: 1