FDA Adverse Event Injury Summary report: N

OLYMPUS

MDR report key: 272905 · Received April 6, 2000

Report

Report Number
8010047-2000-00023
Event Type
Injury
Date Received
April 6, 2000
Date of Event
March 15, 2000
Report Date
March 16, 2000
Manufacturer
THE OLYMPUS OPTICAL CO.
Product Code
LQC
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A HOSPITAL NURSE MANAGER REPORTED THAT DURING AN EDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY PROCEDURE, A STONE BECAME STUCK IN A REUSABLE LITHOTRIPTOR AND WIRE OF THE LITHOTRIPTOR BASKET BECAME EMBEDDED IN THE STONE. WHEN THIS OCCURRED, THE NURSE ATTEMPTED TO TURN THE ROTATABLE KNOB ON THE HANDLE BUT IT ONLY TURNED "A LITTLE" AND NOT AS MUCH AS IT SHOULD. THE NURSE REPORTED THAT THE HANDLE WAS REMOVED AND THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO PULL THE LITHOTRIPTOR WIRE MANUALLY. NEXT, THE NURSE RECONNECTED THE REUSABLE LITHOTRIPTOR TO THE REUSABLE HANDLE. THE NURSE CHECKED THAT THE KNOB ON THE HANDLE WAS "SNAPPED" TOGETHER- NURSE PULLED ON IT TO MAKE SURE THE DEVICE WAS SECURE. THEN, THE NURSE CONTINUED TO ATTACH THE OTHER PARTS OF THE DEVICE AND ONCE AGAIN, NURSE ATTEMPTED TO CRUSH THE STONE. ONCE AGAIN, THE NURSE WAS ABLE TO TURN THE KNOB ON THE HANDLE ONLY "A LITTLE". THE PHYSICIAN WAS ALSO UNSUCCESSFUL IN THE ATTEMPT TO TURN THE KNOB. THE NURSE REPORTED THAT WHEN THE LITHOTRIPTOR WIRE WAS PULLED OUT FROM THE HANDLE, NURSE NOTICED THAT THE METAL COIL SHEATH WAS BENT AND THE PLASTIC SHEATH WAS STUCK. THE NURSE MENTIONED THAT THE SMALL KNOB ON THE SLIDE REGION OF THE LITHOTRIPTOR COULD NOT BE MOVED DOWN THE SHAFT. AT THAT POINT, THE PATIENT WAS TAKEN TO SURGERY WITH THE SCOPE AND LITHOTRIPTOR STILL INSERTED INTO HIS/HER MOUTH. ACCORDING TO THE NURSE, THE PATIENT WAS DOING FINE FOLLOWING THE SURGERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OLYMPUS MECHANICAL LITHOTRIPTOR LQC THE OLYMPUS OPTICAL CO. BML-3Q1 NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Required Intervention