FDA Adverse Event Summary report: N

CUTTING ELECTRODE WITH REPLACEABLE TIP

MDR report key: 4592 · Received April 2, 1993

Report

Report Number
4592
Date Received
April 2, 1993
Report Date
April 2, 1993
Manufacturer
ELMED, INC.
Product Code
GEI
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT UNDERWENT A LAPAROSCOPY ON 10/9/92. THE PROCEDURE PERFORMED WAS A "LAPAROSCOPY WITH UTEROSACRAL NERVE ABLATION." PATIENT WAS READMITTED AT 10:20 ON 10/12/92 WITH BLEEDING AND ABDOMINAL PAIN. AN EXPLORATORY LAPAROTOMY WAS PERFORMED BY GENERAL SURGEON AND ASSISTANT. A PERFORATED RECTUM, PERFORATED VAGINA, AND A PELVIC HEMOTOMA WITH ABSCESS WAS FOUND. THE SECOND PROCEDURE WAS "EXPLORATORY LAPAROTOMY, APPENDECTOMY, COLOSTOMY, REPAIR OF PERFORATED RECTUM AND PERFORATED VAGINA.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CUTTING ELECTRODE WITH REPLACEABLE TIP GEI ELMED, INC. ELECTROTOM120

Patients

Seq Age Sex Outcome Treatment
1 Invalid Data