INDICATOR SHAFT
Received Jan 16, 2017 · Event occurred Dec 1, 2016
Report 1721194-2017-00003 · MDR key 6253901
Device
Generic name
Indicator Shaft
Manufacturer
Megadyne Medical Products, IncModel number
0695SCatalog number
0695S
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
TWO DEVICES WERE RECEIVED AND WERE REPORTED AS 0695S. UPON EXAMINATION OF THE SAMPLES IT WAS FOUND THAT THE DEVICES WERE NOT MANUFACTURED BY MEGADYNE MEDICAL PRODUCTS. WE CONSIDER THIS MATTER TO BE CLOSED.
Additional Manufacturer Narrative
WITHOUT LOT NUMBER INFORMATION, WE ARE UNABLE TO IDENTIFY THE MANUFACTURING DATE. COMPLAINT HISTORY FOR THE LAST 2 YEARS DOES NOT SHOW ANY REPORTS DUE TO THIS SAME REPORT. THE SHAFT IS SOLD AS A NON-STERILE DEVICE AND INDENTED FOR STERILIZATION BY THE USER FACILITY AND INTENDED FOR THE ATTACHMENT OF A STERILE TIP. AT THIS TIME, ALL ATTEMPTS TO GAIN ACCESS TO THE DEVICE OR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. A REVIEW OF PRODUCT HISTORY REVEALS THIS DEVICE TO BE A RELIABLE COMPONENT OF ELECTROSURGERY AND THERE IS NO EVIDENCE TO SUGGEST DEVICE DEFECT OR MALFUNCTION. MEGADYNE DETERMINED TO REPORT THIS EVENT BASED ON INFORMATION THAT A BURN OCCURRED ON THE PATIENT'S FALLOPIAN TUBES AND INTERVENTION MAY HAVE BEEN REQUIRED. MEGADYNE HAS REQUESTED ADDITIONAL INFORMATION AND MADE REQUESTS FOR THE DEVICE TO BE RETURNED FOR FURTHER INVESTIGATION AND EVALUATION.
Description of Event or Problem
TWO (2)X GYNNAE PATIENTS FALLOPIAN TUBES WERE BURNT IN SURGERY WHILE USING MEGATIP AND REUSABLE INDICATOR SHAFT.