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

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Type of procedure performed: lap chole.The account mgr was present for the case, which was part of an evaluation.The initial case was completed with no issues.A 12mm applied trocar was used with the clip applier.Around midnight the patient was brought back into surgery due to bleeding.During surgery it was found that a clip had come loose from the surgical site.As of this morning the patient is doing fine after surgery.It is unknown if the patient required a blood transfusion.There are no photos available.The device from the initial surgery was disposed of after the case.Patient status: patient is fine after 2nd surgery.Type of intervention: the patient required another surgery when clip came loose from surgical site.

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 of clip slippage could not be replicated.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause based on the description of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Type of procedure performed: lap chole.The account mgr was present for the case, which was part of an evaluation.The initial case was completed with no issues.A 12mm applied trocar was used with the clip applier.Around midnight the patient was brought back into surgery due to bleeding.During surgery it was found that a clip had come loose from the surgical site.As of this morning the patient is doing fine after surgery.It is unknown if the patient required a blood transfusion.There are no photos available.The device from the initial surgery was disposed of after the case.Additional information received via email on 08mar2021 from [name]: i met with dr.[name] at her office today (08mar2021) to discuss the incident.She confirmed that the patient experienced bleeding after the initial lap chole and required a secondary procedure to address the issue.Dr.[name] went in laparoscopically and discovered the a clip had come loose, which caused the bleeding.The patient receives 2 units of blood during this time.Dr.[name] was able to fix the issue and the patient is now fine." patient status: patient is fine after 2nd surgery type of intervention: the patient required another surgery when clip came loose from surgical site.

• 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: 11426711
• MDR Text Key: 238330868
• Report Number: 2027111-2021-00373
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)231027(30)01(10)1400102
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1400102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APPLIED 12MM TROCAR
• Patient Outcome(s): Required Intervention