MalfunctionFAM

PROTOSCOPES, SIGMOIDOSCOPES, ACC.

Received Nov 14, 2016 · Event occurred Nov 10, 2016

Report 6098767 · MDR key 6098767

Device

Generic name

Sigmoidoscope And Accessories, Flexible/rigid

Manufacturer

Karl Storz Endoscopy-america, Inc.

Model number

13901NKS

Catalog number

13901NKS

Product problems

Break
Detachment Of Device Component

Patient

Not reported

No Information
No Information

Narrative

Description of Event or Problem

WHILE REMOVING THE VIDEO SIGMOIDOSCOPE FROM THE LIGHT SOURCE, THE SIGMOIDOSCOPE BODY SEPARATED FROM THE LIGHT SOURCE CONNECTION AND THE FLEXIBLE ENDOSCOPE SHEATH. THIS IS THE SECOND OCCURRENCE OF THIS TYPE OF FAILURE ON THIS SIGMOIDOSCOPE MODEL. REVIEW WITH THE USER INDICATED THAT THEY DID FOLLOW CORRECT REMOVAL PROCEDURE. THIS SCOPE WAS THE EXCHANGE SCOPE REPLACING A SCOPE THAT HAD THE SAME DAMAGE WITH SEPARATION OF THE LIGHT CONNECTOR BODY AND FLEXIBLE SHEATH. MANUFACTURER RESPONSE FOR VIDEO SIGMOIDOSCOPE, (BRAND NOT PROVIDED) (PER SITE REPORTER: MANUFACTURER NOTED THIS WAS A WARRANTY DEVICE DELIVERED TWO MONTHS AGO. MANUFACTURER CALLED UNIT IN. BIOMEDICAL ENGINEERING IS REQUESTING REPORT ON FAILURE.