inforMED
MalfunctionFFZ

A CORD

Received Jun 13, 2014 · Event occurred May 16, 2014

Report 8010047-2014-00310 · MDR key 3958438

Device

Generic name

A Cord

Model number

MH-969

Catalog number

NA

Lot number

UNK

Product problems

  • Break

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING POLYPECTOMY OF COLON THE DOCTOR GOT AN ERROR TRYING TO ACTIVATE OUTPUT WHILE HE SNARED THE TARGET POLYP AND OUTPUT COULD NOT BE ACTIVATED . THEN HE NOTICED THAT THE SUBJECT PRODUCT BROKE. HE EXCHANGED THE SUBJECT PRODUCT AND THE ELECTROSURGICAL UNIT FOR OTHER DEVICES AND COMPLETED THE PROCEDURE. THERE WAS NO REPAIR OF PATIENT INJURY REGARDING THIS REPORT.

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CABLE BROKE NEAR A CODE PLUG. THE CABLE CORE WAS BURNT AND THE BROKEN OUT SECTION WAS DISCOLORED. OMSC WAS INFORMED THAT THE USER FACILITY HAD USED THE SUBJECT DEVICE FOR NEARLY 10 YEARS. OMSC ASSUMES THAT BENDING LOAD WAS PUT ON THE CABLE REPEATEDLY OVER LONG PERIODS AND IT CAUSED THE BREAKAGE OF THE CABLE CORE. IN ADDITION, THE USER FACILITY CONTINUED TO USE THE SUBJECT DEVICE WITH THE CABLE CORE BROKEN, IT CAUSED THIS EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVIC REPORT IN AN ABUNDANCE OF CAUTION.