OLYMPUS-KEYMED
Received Oct 17, 1997 · Event occurred Aug 1, 1997
Report 9611174-1997-00002 · MDR key 126915
Device
Generic name
Esophageal Dilator
Manufacturer
Keymed (medical & Industrial Equipment) Ltd.Model number
KAD-1 SMALL DILATOR (20-27FR)Catalog number
7094124 (DILATOR PART NO)
Lot number
*
Narrative
Description of Event or Problem
A VERBAL REPORT WAS RECEIVED FROM THE MEDICAL PHYSICS ENGINEER ON 1997, INDICATING THAT THE SMALL DILATOR (20-27FR) FROM A KEYMED MANUFACTURED KAD-1 KIT HAD SPLIT DURING USE. HE ASKED IF THE OTHER TWO DILATORS FROM THE KIT COULD BE RETURNED FOR EXAMINATION. NO INDICATION OF ANY INJURY TO A PATIENT WAS GIVEN. THE OTHER TWO DILATORS WERE EXAMINED AND TESTED BY KEYMED AND RETURNED TO THE HOSPITAL AS THEY WERE DEEMED TO BE FIT FOR FURTHER USE. ON 9-1-1997, KEYMED RECEIVED A LETTER FROM THE UK MEDICAL DEVICES AGENCY (MDA), WITH A COPY OF AN INCIDENT REPORT FROM THE HOSPITAL, STATING THAT THE PATIENT SUFFERED A PERFORATED ESOPHAGUS AS A RESULT OF THE INCIDENT. ON 10-3-1997, KEYMED RECEIVED A FURTHER COMMUNICATION FROM THE MDA, TO REPORT THAT THE PATIENT HAD SINCE DIED. KEYMED HAS ASKED THE MDA TO ASSIST IN MAKING THE SUJECT DILATOR AVAILABLE FOR INVESTIGATION.