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 02/25/2019

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap cholecystectomy "on the morning of (b)(6) 2019 surgeon was performing a lap cholecystectomy when the universal clip applier misfired (spit clip out).He got a second universal clip applier and completed the procedure.Later that same day the patient came back to the hospital with an elevated heart rate & low blood pressure, indicating bleeding.He attempted to correct the situation laparoscopically and observed excessive clotting in the liver bed area.He placed a drain in.He later observed the patient was continuing to bleed and gave the patient 2 units of blood.At this point the surgeon decided to open the patient and was able to stop the bleeding.There were no further issues with the patient after this." additional information was received via email on (b)(4) 2019 from account manager.The unit was discarded.Additional information was received via email on (b)(4) 2019 from account manager the surgeon couldn¿t say for sure that the clip failing to occlude the vessel was the cause of the bleeding but it appeared to be.Additional information was received via email on 02apr2019 from applied medical account manager.I was able to find out that one clip was placed from the first clip applier before the failure.The second clip wasn¿t fully closed so the surgeon asked for the second clip applier and then finished the case with it.Patient status: patient had to return to the hospital for additional treatment.There were no further issues with the patient after this.

Event Description

Procedure performed: lap cholecystectomy."on the morning of on (b)(6) 2019, surgeon was performing a lap cholecystectomy when the universal clip applier misfired (spit clip out).He got a second universal clip applier and completed the procedure.Later that same day the patient came back to the hospital with an elevated heart rate & low blood pressure, indicating bleeding.He attempted to correct the situation laparoscopically and observed excessive clotting in the liver bed area.He placed a drain in.He later observed the patient was continuing to bleed and gave the patient 2 units of blood.At this point the surgeon decided to open the patient and was able to stop the bleeding.There were no further issues with the patient after this." additional information was received via email on 11mar2019 from account manager.The unit was discarded.Additional information was received via email on 18mar2019 from account manager the surgeon couldn¿t say for sure that the clip failing to occlude the vessel was the cause of the bleeding but it appeared to be.Additional information was received via email on 02apr2019 from applied medical account manager.I was able to find out that one clip was placed from the first clip applier before the failure.The second clip wasn¿t fully closed so the surgeon asked for the second clip applier and then finished the case with it.Patient status: patient had to return to the hospital for additional treatment.There were no further issues with the patient after this.

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 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: 8485120
• MDR Text Key: 141018451
• Report Number: 2027111-2019-00405
• Device Sequence Number: 1
• Product Code: FZP
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization