inforMED
MalfunctionLMC

*

Received Jun 26, 2013 · Event occurred Jun 25, 2013

Report 3203946 · MDR key 3203946

Device

Generic name

Camera, Surgical And Accessories

Model number

UP-5600MDU/S

Catalog number

*

Lot number

*

Product problems

  • Poor Quality Image

Patient

26 YR

  • No Information

Narrative

Description of Event or Problem

DURING THE SURGICAL PROCEDURE, SOME ANATOMICAL PICTURES WERE TAKEN WITH THE LAPAROSCOPIC CAMERA. THE IMAGES ON THE MONITORS WERE CLEAR BUT ONCE THEY WERE PRINTED, THEY APPEARED TO BE EXTREMELY OVER EXPOSED. BIO MEDICAL WAS CALLED MULTIPLE TIMES PRIOR TO THEM ANSWERING THE PAGE. ONCE THEY ANSWERED, THEY CAME TO THE ROOM AND NO RESOLUTION WAS GIVEN TO THE PROBLEM. BIO MEDICAL SAID THAT THEY WOULD HAVE TO COME AT THE END OF THE PROCEDURE TO INSPECT THE PRINTER/CAMERA TOWER. ONCE THE PROCEDURE WAS COMPLETED, BIO MED WAS CALLED ONCE AGAIN AND THEY RETURNED TO THE ROOM. AFTER INSPECTING, NO REASONING WAS PROVIDED AS TO WHAT CAUSED THE IMAGES TO BE CLEAR ON THE MONITOR SCREENS AND TO APPEAR EXTREMELY OVER EXPOSED ON THE PRINTED PICTURES. THE CAPTURED IMAGES WERE NOT ABLE TO BE PRINTED CLEARLY AND THEREFORE, THE SURGEON WAS NOT ABLE TO PUT THOSE IMAGES INTO THE PATIENT'S RECORD.