MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation. The exact cause of the reported event could not be determined at this time. In addition, insufficient information regarding the reported device, patient and procedure was reported. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available, this report will be updated and supplemented accordingly. However, based on the reported information the operator¿s technique cannot be ruled out as a contributory factor. The olympus sales representative reported that the most probable cause of the reported event could be attributed to both the ucr and clv-190 air supply being on at the same time. The instruction manual for the ucr warns, ¿during use, always stop the device like light source from supplying air. If stop is not selected, a mixture of air and co2 may be supplied into the patient body. ¿ in addition, the instruction manual for the clv-190 (section 5. 9) also provides warning that states, ¿over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation. ¿.

Event Description

Olympus was informed that during a pneumoperitineum procedure, the patient¿s cecum was perforated. The patient was given versed and sentinol for sedation and the procedure lasted 30 minutes. The air from the light source (clv-190) and co2 from the regulation unit (ucr) were used simultaneously during the procedure as the physician switched back and forth between air and co2. The physician noted that both the air and co2 were on at the same time. A few hours after the procedure was completed, while the patient was in recovery, the patient experienced abdominal pain. It was determined that the patient needed a surgical procedure to treat a cecal perforation. 2 of 2 devices.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7970381
• MDR Text Key: 123867064
• Report Number: 2951238-2018-00623
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLV-190
• Device Catalogue Number: CLV-190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/16/2018 Patient Sequence Number: 1

Treatment

COLONOSCOPE: OLYMPUS CF-HQ190L, SERIAL: UNKNOWN; REGULATION UNIT: OLYMPUS UCR, SERIAL: UNKNOWN; TUBING FOR UCR: MEDIVATOR MODEL/SERIAL: UNKNOWN