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

Model Number CA500

Device Problem Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Thrombosis/Thrombus (4440)

Event Date 07/30/2022

Event Type  Injury  

Manufacturer Narrative

The event unit is not anticipated to return to applied medical.A follow-up report will be provided upon completion of the investigation.This report is to follow-up medwatch #mw5111448.

Event Description

Procedure performed: laparoscopic cholecystectomy.Complaint created based off medwatch #mw5111448.Patient underwent a laparoscopic cholecystectomy 2 days prior to event.Patient taken to the operating room when he began having signs of shock on post-op day 2.The patients hemoglobin the morning of the second surgery was 10 and later the afternoon had dropped to 4.An upper midline laparotomy was performed and the surgeon identified clots and blood in the abdomen.After blood and clot evacuation, 2 loose hemoclips were identified.Patient status: patient hemoglobin dropped to 4.Surgeon identified clots and blood in the abdomen.Intervention: blood and clot evacuation performed.

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: complaint created based off medwatch #mw5111448.Patient underwent a laparoscopic cholecystectomy 2 days prior to event.Patient taken to the operating room when he began having signs of shock on post-op day 2.The patients hemoglobin the morning of the second surgery was 10 and later the afternoon had dropped to 4.An upper midline laparotomy was performed and the surgeon identified clots and blood in the abdomen.After blood and clot evacuation, 2 loose hemoclips were identified.Additional information received on 26aug2022 via email from [name], ligation manager.: some surgeons at the facility had not been in-serviced/educated regarding device use.Some surgeons declined request for inservice/education and proceeded to use the product.Patient status: blood and clot evacuation performed.Intervention: patient hemoglobin dropped to 4.Surgeon identified clots and blood in the abdomen.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.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 exact root cause of the event.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: complaint created based off medwatch #mw5111448.Patient underwent a laparoscopic cholecystectomy 2 days prior to event.Patient taken to the operating room when he began having signs of shock on post-op day 2.The patients hemoglobin the morning of the second surgery was 10 and later the afternoon had dropped to 4.An upper midline laparotomy was performed and the surgeon identified clots and blood in the abdomen.After blood and clot evacuation, 2 loose hemoclips were identified.Additional information received on 26aug2022 via email from [name], ligation manager.: some surgeons at the facility had not been in-serviced/educated regarding device use.Some surgeons declined request for inservice/education and proceeded to use the product.Patient status: patient hemoglobin dropped to 4.Surgeon identified clots and blood in the abdomen.Intervention: blood and clot evacuation performed.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15324864
• MDR Text Key: 298949986
• Report Number: 2027111-2022-00717
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other