MAUDE Adverse Event Report: LITHOTOMY STIRRUP; TABLE AND ATTACHMENTS, OPERATING-ROOM

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923); Device Fell (4014)

Patient Problems Fall (1848); Pain (1994)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Patient prepped and draped in lithotomy position.Md (doctor) went to elevate right leg, and post of stirrup was dislodged and dropped/resting on floor.Patient's leg was supported, stirrup removed, and new stirrup placed on bed in attachment and leg secured.Md informed husband of incident and advised to call if increased pain to hip.The initial post was behind attachment between rail and bed.On event report this is attributed to "user error." there is not any device specific information (serial#, brand name) given on report.

• Brand Name: LITHOTOMY STIRRUP
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• MDR Report Key: 13759150
• MDR Text Key: 287602108
• Report Number: 13759150
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Sex: Female