FDA Adverse Event Malfunction Summary report: N

AMSCO DAD TABLETOP PADS-3080

MDR report key: 91267 · Received May 9, 1997

Report

Report Number
91267
Event Type
Malfunction
Date Received
May 9, 1997
Date of Event
March 28, 1997
Report Date
April 4, 1997
Manufacturer
STERIS CORP.
Product Code
FWZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT WAS SCHEDULED FOR AN EXPLORATORY LAPAROSCOPY. THE EXPLORATORY LAPAROSCOPY REVEALED A RUPTURED ECTOPIC PREGNANCY. PT STARTED TO HEMORRHAGE SO PT WAS OPENED. NO INSTRUMENT COUNT WAS DONE BEFORE PT WAS OPENED; HOWEVER, A SPONGE AND LAP COUNT HAD BEEN DONE BEFORE THE BEGINNING OF THE PROCEDURE. AT THE END OF THE PROCEDURE ABDOMINAL X-RAY WAS REQUESTED BY THE RN CIRCULATOR. AGREED TO THE X-RAY, X-RAY REVEALED WHAT APPEARED TO BE A DISK IN THE LEFT LOWER QUADRANT OF THE ABDOMEN, AND THE RN CIRCULATOR CHECKED THE LINENS, UNDER THE PT AND FOUND NO DISK. ANOTHER X-RAY WAS TAKEN AND THE DISK APPEARED TO HAVE MOVED FARTHER TO THE LEFT OF THE ABDOMEN. AT THIS POINT, ALL ECG LEADS WERE REMOVED FROM THE PT. ANOTHER X-RAY (THIRD) REVEALED THE DISK WAS STILL HERE. PT WAS THEN PREPPED AND OPENED FOR AN EXPLORATORY. ONCE IN ABDOMEN, THE SURGEON WAS UNABLE TO LOCATE A DISK. ORDERED A C-ARM FOR DIRECT FLUOROSCOPY AND DISK WAS NOT SEEN. DR REQUESTED THE PRESENCE OF DR FOR CONSULTATION. DR REQUESTED A COMPLETE FLUOROSCOPY OF THE ABDOMEN. NO DISK WAS SEEN. BOTH PHYSICIANS AGREED THAT THERE WAS NO DISK IN THE ABDOMEN. PT WAS CLOSED AND TRANSPORTED TO PACU. FOLLOWING THE PROCEDURE, THE OR TABLE PAD WAS TAKEN TO RADIOLOGY AND THE DISK WAS NOTED IN THE PAD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AMSCO DAD TABLETOP PADS-3080 TABLE ACCESSORY-SEAT/BACK SECTION PAD FWZ STERIS CORP. 134469-292 *

Patients

Seq Age Sex Outcome Treatment
1 34 YR Other