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 Injury (2348)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: cholezystektomie / cholecystectomy.It has happened that the clip applicator has not fired several times and sometimes the clips have not closed properly.One patient had recurrent surgery because the cystic duct was not occluded.This was then closed with competitor clip.After that good progress.Patient status: re-operated.After that good recovery.

Event Description

Procedure performed: cholezystektomie / cholecystectomy it has happened that the clip applicator has not fired several times and sometimes the clips have not closed properly.One patient had recurrent surgery because the cystic duct was not occluded.This was then closed with competitor clip.After that good progress.Patient status: re-operated.After that good recovery.

Manufacturer Narrative

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 has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction 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: 9301427
• MDR Text Key: 165760272
• Report Number: 2027111-2019-00630
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220326(30)01(10)1352668
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1352668
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization