MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. UNIVERSAL CLIP APPLIER 5MM; CLIP, IMPLANTABLE

Model Number 50242258

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/30/2022

Event Type  Injury  

Event Description

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.Fda safety report id# (b)(4).

• Brand Name: UNIVERSAL CLIP APPLIER 5MM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.
• MDR Report Key: 15216971
• MDR Text Key: 297912787
• Report Number: MW5111448
• Device Sequence Number: 2
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 50242258
• Device Catalogue Number: CA500
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male