FDA Adverse Event Injury Summary report: N

PENTAX VIDEO PROCESSOR

MDR report key: 190849 · Received September 1, 1998

Report

Report Number
190849
Event Type
Injury
Date Received
September 1, 1998
Date of Event
August 21, 1998
Report Date
September 1, 1998
Manufacturer
ASAHI OPTICAL CO., LTD./MEDICAL INSTRUMENT DIVISION
Product Code
KOG
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

TWO DAYS POST ADMISSION FOR MANAGEMENT AND EVALUATION OF ABDOMINAL PAIN AND FECAL IMPACTION, THE PT WAS TRANSFERRED TO THE ENDOSCOPY SUITE FOR A COLONOSCOPY IN ORDER TO RULE OUT COLOINC CARCINOMA. THE VIDEO COLONOSCOPE WAS PASSED WITHOUT DIFFICULTY TO THE DISTAL TRANSVERSE COLON, BUT, WAS UNABLE TO BE ADVANCED FURTHER BECAUSE OF THE PRESENCE OF RETAINED FECAL MATERIAL. THE PROCEDURE WAS TERMINATED, THE SCOPE WAS REMOVED AND THE PT WAS TRANSFERRED BACK TO HER ROOM IN STABLE CONDITION. APPROX TWO HOURS LATER, THE PT'S ABDOMEN WAS NOTED TO BE GROSSLY DISTENDED. HER GASTROENTEROLOGIST ORDERED COMPUTERIZED TOMOGRAPHY SCAN EVALUATION; THE PT, HOWEVER, FOUND IT DIFFICULT TO DRINK THE CONTRAST MEDIA IN PREPARATION FOR THIS EXAMINATION. A RECTAL TUBE WAS INSERTED SEVERAL TIMES TO RELIEVE HER GAS PRESSURE. AN ABDOMINAL X-RAY LATER IN THE DAY REVEALED MARKED ITEMS WITH PROBABLE FREE INTRAPERITONEAL AIR. A SURGICAL CONSULT WAS REQUESTED AND THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. A CECAL PERFORATION WITH FREE SPILLAGE OF STOOL WITHIN THE ABDOMEN, ACUTE PERITONITIS, MULTIPLE ADHESIONS AND MECKEL'S DIVERTICULITIS WERE IDENTIFIED. A RIGHT HEMICOLECTOMY WITH A DIVERTING ILEOSTOMY AND MUCOUS FISTULA. MECKEL'S DIVERTICULECTOMY, ILEOCOLECTOMY AND LEFT SALPHINGO-OOPHORECTOMY WERE PERFORMED AND SHE WAS TRANSFERRED, INTUBATED, BACK TO THE INTENSIVE CARE UNIT. THE PT'S POSTOPERATIVE PERIOD HAS BEEN COMPLICATED BY RESPIRATORY AND RENAL FAILURE. SHE IS CURRENTLY STILL HOSPITALIZED IN THE FACILITY AND RECEIVING, PER HER FAMILY'S WISHES, ONLY SUPPORTIVE CARE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PENTAX VIDEO PROCESSOR VIDEO PROCESSOR KOG ASAHI OPTICAL CO., LTD./MEDICAL INSTRUMENT DIVISION EPM-3300 *

Patients

Seq Age Sex Outcome Treatment
1 84 YR Required Intervention