TRIVEX MDU
Received Sep 8, 2006 · Event occurred Aug 9, 2006
Report 1643264-2006-00061 · MDR key 876042
Device
Generic name
*
Manufacturer
Smith & Nephew Inc., Endoscopy Div.Model number
7210387Catalog number
7210387
Lot number
*
Product problems
- Loose or Intermittent Connection
- Repair
- Device Inoperable
- Device Issue
- Difficult or Delayed Activation
Patient
73 YR
- Surgical procedure aborted/stopped
- Surgical procedure, delayed
Narrative
Description of Event or Problem
PRIOR TO THE PHLEBECTOMY PROCEDURE, THE UNIT TURNED THE MACHINE OFF. PATIENT HAS BEEN GIVEN "MAC" ANESTHESIA AND HAD BEEN SEDATED. THE MDU WAS RECOGNIZED BY THE CONTROL UNIT, BUT WOULD NOT ACTIVATE THE RESECTOR. RESECTOR COULD BE TURNED BY HAND OUTSIDE OF THE MDU. TRIVEX CONTROL UNIT WAS NOTED TO HAVE A LOOSE MDU CONNECTION PORT. CONNECTION WAS TIGHTENED BUT THE MDU WOULD NOT OPERATE. OR SUPERVISOR STATED THE CASE WAS RESCHEDULED AND WAS COMPLETED WITHOUT COMPLICATIONS.
Additional Manufacturer Narrative
PINS ON THE UNIT CONNECTOR WERE BENT AND THE CORD WOULD NOT FIT FLUSH WITH THE HANDPIECE. DAMAGE TO PINS APPEAR TO HAVE OCCURRED AT CUSTOMER SITE. CONCLUSION: IMPROPER USE.