MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS, INC. STIRRUP; OPERATING ROOM ACCESSORIES TABLE TRAY

Device Problems Bent (1059); Break (1069); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2016

Event Type  malfunction  

Event Description

Patient in stirrups for colonoscopy procedure.During the case, the right stirrup with the patient's right leg in the stirrup, fell.Staff member immediately lifted the leg manually up while the leg was still in the stirrup.The stirrup was noted to be broken at the joint and bent where the stirrup attached to the bed.A new stirrup retrieved by a staff member was placed on the bed without difficulty.The patient did not experience any ill effects from this event and was discharged shortly after surgery (1 day later).

• Brand Name: STIRRUP
• Type of Device: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• MDR Report Key: 6124710
• MDR Text Key: 60787679
• Report Number: 6124710
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2016,09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 17 YR
• Patient Weight: 143