MAUDE Adverse Event Report: MEDTRONIC OCTOBASE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Problem Component Missing (2306)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

Upon placement of retractor into chest cavity during coronary artery bypass graft procedure, provider immediately noticed that a piece of the disposable octobase component was missing.Assembly table, surgical field and patient's body cavity were searched.X-ray was taken per operating room policy, no retained object found.Fda safety report id # (b)(4).

• Brand Name: OCTOBASE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 15864940
• MDR Text Key: 304423996
• Report Number: MW5113479
• Device Sequence Number: 1
• Product Code: DWS
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White