FDA Adverse Event Injury Summary report: N

GLIDESCOPE

MDR report key: 5881947 · Received August 15, 2016

Report

Report Number
MW5064130
Event Type
Injury
Date Received
August 15, 2016
Date of Event
March 24, 2016
Report Date
August 5, 2016
Manufacturer
VERATHON INC.
Product Code
CCW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2016 I HAD A LAPAROSCOPIC CHOLECYSTECTOMY WITH GENERAL ANESTHESIA. MY PHYSICIAN USED A GLIDESCOPE FOR INTUBATION WHEN I REQUESTED USE OF FIBEROPTIC INTUBATION DUE TO WHAT HAS BEEN USED SUCCESSFULLY IN PAST DIFFICULT INTUBATIONS. POST OP I DEVELOPED A PNEUMOTHORAX AND PULMONARY EFFUSION AS WELL AS 2 BROKEN BACK MOLAR CAPS. HOSPITAL STAY WENT FROM THE EXPECTED 3 DAYS TO 9 DAYS IN PCU. ONCE HOME, I NOTICED THAT OVER 6,300 GLIDESCOPES HAD BEEN RECALLED IN THE FEW WEEKS PRIOR TO MY SURGERY. I ASKED THE HOSPITAL CORPORATE RISK MANAGER, IN CONJUNCTION TO A REVIEW OF MY CASE, TO GIVE ME THE SERIAL/MODEL NUMBER OF THE GLIDESCOPE. I WANTED TO RELEASE MYSELF OF ANY CONCERNS THAT A RECALLED PRODUCT WAS USED IN MY SURGERY. MY REQUEST WAS REFUSED. I WAS REFERRED TO MY MEDICAL RECORDS WHICH NOTED IT'S USE BUT NOT IT'S IDENTIFYING INFORMATION. I HAVE LETTERS TO VERIFY THIS. MY CONCERNS HAVE BEEN SHARED WITH THE PHYSICIANS INVOLVED IN THIS CASE. THE ANESTHESIOLOGIST WAS DR. (B)(6) AND THE SURGEON WAS DR. (B)(6), BOTH OF (B)(6). ARE YOU ABLE TO TELL ME IF (B)(6) HAD THE RECALLED GLIDESCOPES AMONG THEIR INVENTORY AND IF ALL OF THE ITEMS WERE DECOMMISSIONED? WAS THE GLIDESCOPE USED CORRECTLY? THIS HAS BEEN A HUGE FINANCIAL, PHYSICAL, EMOTIONAL AND TIME PROBLEM FOR ME DUE TO THE MEDICAL COMPLICATIONS AND FUTURE RISKS. I HAVE STAGE 4 CANCER AND NEED TO DEVOTE THIS TIME AND ENERGY TO MY HEALING AND SURVIVAL FROM CANCER NOT FIGHTING A HOSPITAL OR PHYSICIAN. IF YOU CANNOT HELP ME PLEASE ADVISE ME AS TO WHERE I SHOULD GO WITH MY CONCERNS ABOUT POTENTIAL SAFETY ISSUES WITH MEDICAL DEVICES. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
527761 GLIDESCOPE GLIDESCOPE CCW VERATHON INC.

Patients

Seq Age Sex Outcome Treatment
1 65 YR Hospitalization| O| R| S