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 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Ra has received the event device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.

Event Description

Procedure performed: lap cholecystectomy.Surgeon had 4 lap choles on list.During 4th lap chole, 3rd clip was applied on cystic artery.Surgeon applied clip by closing handle plastic to plastic.Clip was loose on cystic artery; when surgeon checked clip with grasper, clip moved freely on artery.This clip was left on artery.Another clip was applied next to loose clip.When surgeon applied, it was applied plastic to plastic and surgeons squeezed for few seconds for clip placement.Artery was cut using scissors.Surgeon was then concerned that 4th clip applied may be loose so used diathermy hook to coagulated cystic artery (patient side) next to clip.Patient status: no injury occurred.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However the complainant¿s experience of incomplete clip closure could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.As all returned clips loaded and closed properly, the exact root cause of the reported event could not be determined.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

Event Description

Procedure performed: lap cholecystectomy.Surgeon had 4 lap choles on list.During 4th lap chole, 3rd clip was applied on cystic artery.Surgeon applied clip by closing handle plastic to plastic.Clip was loose on cystic artery; when surgeon checked clip with grasper, clip moved freely on artery.This clip was left on artery.Another clip was applied next to loose clip.When surgeon applied, it was applied plastic to plastic and surgeons squeezzed for few seconds for clip placement.Artery was cut using scissors.Surgeon was then concerned that 4th clip applied may be loose so used diathermy hook to coagulated cystic artery (patient side) next to clip.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: 8538277
• MDR Text Key: 142790279
• Report Number: 2027111-2019-00433
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220109(30)01(10)1345964
• 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: 06/14/2019

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: 01/09/2022
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1345964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1