MAUDE Adverse Event Report: STRYKER / HOWMEDICA OSTEONICS CORP. JAVID CLAMP; FORCEPS

Model Number 2107-0006

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Vascular Dissection (3160)

Event Date 03/13/2023

Event Type  Injury  

Event Description

During a right carotid endartectomy, the provider made an incision on the right side of the neck and exposed the right carotid artery.A javid clamp was placed on the right common carotid artery.It needed to be readjusted and upon doing so, the clamp tore the right common carotid artery.Another javid clamp was opened to the field and exchanged.The provider was able to repair the torn artery and was able to complete the procedure.

• Brand Name: JAVID CLAMP
• Type of Device: FORCEPS
• Manufacturer (Section D): STRYKER / HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 16770783
• MDR Text Key: 313639672
• Report Number: MW5116814
• Device Sequence Number: 1
• Product Code: HTD
• 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: 04/13/2023

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 Model Number: 2107-0006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White