FDA Adverse Event Injury Summary report: N

PENTAX

MDR report key: 394742 · Received May 15, 2002

Report

Report Number
394742
Event Type
Injury
Date Received
May 15, 2002
Date of Event
March 28, 2002
Report Date
April 11, 2002
Manufacturer
ASAHI OPTICAL CO., LTD.
Product Code
GCK
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON THE DAY OF THE EVENT, A PT WAS ELECTIVELY ADMITTED TO THIS FACILITY FOR UPPER AND LOWER ENDOSCOPIC EVAL. THE PT'S MEDICAL HISTORY INCLUDED HYPERTENSION, ASTHMA, GASTROESOPHAGEAL REFLUX DISORDER (GERD) AND GASTRIC ULCER. OF NOTE, A UVULOPHARYNGEAL PALATOPLASTY HAD BEEN PERFORMED WITH A TONSILLECTOMY DURING 1992, TEN YEARS PRIOR TO THIS ADMISSION, FOR MANAGEMENT OF SLEEP APNEA SYNDROME AND CHRONIC TONSILLITIS. AFTER BEING SEDATED WITH INTRAVENOUS VERSED AND DEMEROL, AND ANESTHETIZED WITH TOPICAL CETACAINE, ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS ATTEMPTED BY GASTROENTEROLOGIST. THE PROCEDURE WAS TERMINATED AFTER THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY PASS FIRST THE ADULT-SIZED GASTROSCOPE AND THEN THE PEDIATRIC-SIZED GASTROSCOPE PASS THE PHARYNGOESOPHAGEAL JUNCTION. EXAMINATION OF THE COLON OF THE HEPATIC FLEXURE WAS THEN SUCCESSFULLY COMPLETED AND THE PT WAS TRANSFERRED BACK TO PT'S ROOM. THE POST-DISCHARGE PLAN WAS TO INCLUDE A GI SERIES WITH CERVICAL ESOPHAGRAM FOR EVAL OF PT'S UPPER GASTROINTESTINAL TRACT. APPROX TWO HOURS AFTER RETURNING TO ROOM, THE PT COMPLAINED OF SEVERE THROAT PAIN. PT REFUSED TO WAIT, HOWEVER, FOR DELIVERY OF CEPACOL LOZENGES ORDERED BY PHYSICIAN AND PT WAS DISCHARGED WITH INSTRUCTIONS TO CONTACT PHYSICIAN IF THE PAIN CONTINUED. APPROX ONE AND A HALF HOURS AFTER DISCHARGE, THE PT PRESENTED TO THE ER COMPLAINING OF CHEST AND SEVERE THROAT PAIN. AFTER BEING EXAMINED BY PHYSICIAN PT WAS TRANSFERRED TO THE RADIOLOGY DEPT WHERE A NECK CT SCAN REVEALED AIR IN PT'S NECK AND A GASTROGRAFFIN SWALLOW TEST REVEALED EXTRAVASATION OF CONTRAST MEDIA AROUND THE T5-6 LEVEL. A THORACIC SURGEON WAS CALLED IN TO CONSULT AND THE PT WAS OFFERED THE OPTIONS OF EITHER IMMEDIATE NECK EXPLORATION TO ASSESS THE TEAR OR CONSERVATIVE TREATMENT WITH ANTIBIOTICS AND NPO STATUS FOR SEVERAL DAYS. ALTHOUGH THE PT PREFERRED CONSERVATIVE TREATMENT, SURGICAL MANAGEMENT WAS DEEMED NECESSARY TWO DAYS AFTER PT'S READMISSION. PT WAS TRANSPORTED TO THE OR WHERE A NECK EXPLORATION WITH DRAINAGE OF A PERI-ESOPHAGEAL ABSCESS WAS PERFORMED A CORRECT A PERFORATION FOUND IN THE ESOPHAGUS. THE PT STEADILY RECOVERED FROM THE SURGICAL PROCEDURE, AND AFTER AN ESOPHAGRAM DID NOT REVEAL EXTRAVASATION OF CONTRAST MATERIAL, PT WAS DISCHARGED IN SATISFACTORY CONDITION. THE EQUIPMENT USED DURING THIS PROCEDURE WAS SEQUESTERED AND INSPECTED BY THE FACILITY'S BIO-MEDICAL ENGINEERING DEPT. NO MALFUNCTIONS OR DEFECTS WERE IDENTIFIED. DISCUSSIONS WITH THE GASTROENTEROLOGIST AND THE ASSISTING NURSE REVEALED THAT THERE HAD BEEN NO PROBLEM WITH ANY OF THE EQUIPMENT USED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PENTAX VIDEO GASTROSCOPE(S) GCK ASAHI OPTICAL CO., LTD. EG-2930/EG-2731 NA

Patients

Seq Age Sex Outcome Treatment
1 62 YR Other| R PRODUCT: 1. LIGHT SOURCE, MFR: PENTAX,| 3. VIDEO PRINTER, SONY, UP-5200MD.| MODEL#: EPM3300,| 2. MONITOR, SONY, PVM1343MD,