ADULT HEX HANDLE SUMP SUCKER TIP
Received Feb 15, 2013 · Event occurred Dec 11, 2012
Report 1625519-2013-00001 · MDR key 2969898
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
USER CALLED MFR (NOVOSCI CORP.) AND INQUIRED ABOUT THE RADIOPACITY OF THE ADULT HEX HANDLE SUMP SUCKER TIP (P/N 201190-000) BECAUSE THE TIP HAD FALLEN OFF DURING SURGERY.
Additional Manufacturer Narrative
THE MFR (NOVOSCI CORP.) IS UNCERTAIN IF THE SUSPECT MEDICAL DEVICE THAT MALFUNCTIONED WAS, IN FACT, MANUFACTURED BY THEM. ADDITIONALLY, ALL ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE USER (THE REPORT SOURCE) WERE UNSUCCESSFUL. THEREFORE, THE MFR (NOVOSCI CORP.) CANNOT IDENTIFY THE SUSPECT MEDICAL DEVICE LOT NUMBER, EXPIRATION DATE, DEVICE MFG DATE, NOR ANY INFO PERTAINING TO THE PT (OTHER THAN THAT THE PT IS "OK", ACCORDING TO THE USER - THE REPORT SOURCE). THE MFR (NOVOSCI CORP). ALSO ASKED THE USER (THE REPORT SOURCE) FOR EITHER (A) PHOTOGRAPHS OF THE SUSPECT MEDICAL DEVICE, OR (B) THE RETURN OF THE SUSPECT MEDICAL DEVICE ALONG WITH ANY OF ITS BROKEN PIECES. THE USER (THE REPORT SOURCE) WAS UNRESPONSIVE TO BOTH REQUESTS AND MENTIONED THAT THEY ARE "NOT FILING A COMPLAINT". DURING THE INITIAL 24 HOURS WHEN THE USER CONTACTED THE MFR (NOVOSCI CORP). TO INQUIRE ABOUT THE RADIOPACITY OF THE SUCKER TIP, NOVOSCI'S REGULATORY CONSULTANT WAS NOTIFIED, WHEREIN THE REGULATORY CONSULTANT CONCLUDED THAT THIS INQUIRY SHOULD NOT BE CONSIDERED A COMPLAINT. IN ADDITION, AN MDR DETERMINATION FORM WAS COMPLETED AND IT INDICATED THAT AN MDR FOR THIS INQUIRY WAS NOT REQUIRED. DURING A STAFF MEETING ON (B)(4) 2013, THE REGULATORY CONSULTANT REVISED THE EARLIER JUDGMENT REGARDING THE INQUIRY AND CONCLUDED THAT AN MDR SHOULD, IN FACT, BE INITIATED FOR THIS INQUIRY OF THE SUCKER TIP.