MAUDE Adverse Event Report: UNKNOWN SURGICAL TABLE ATTACHMENT USED T; TABLE AND ATTACHMENTS, OPERATING-ROOM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2022

Event Type  Injury  

Event Description

Situation: one of two or table attachments was broken last week.Background: one attachment had already been placed out of service needing repair.Assessment: this left the or without this specific table attachment.This attachment is needed to perform shoulder surgeries.Recommendation: two shoulder procedures needed to be canceled for tomorrow.A work order was placed today to repair the or table attachment.(b)(6).Fda safety report id # (b)(4).

• Brand Name: SURGICAL TABLE ATTACHMENT USED T
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): UNKNOWN; temple TX
• MDR Report Key: 15906440
• MDR Text Key: 304873078
• Report Number: MW5113598
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male