MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

Device Problem Device Operational Issue (2914)

Patient Problem Perforation (2001)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

The referenced co2 regulation unit was not returned to olympus for evaluation.The cause of the reported event could not be determined at this time.However, user handling could not be ruled out as a contributory factor to the reported event.The instruction manual warns users when the endoscopic co2 regulation unit is used in combination with the upper/lower gastrointestinal endoscope that, 1) over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism and/or perforation.2) anytime you observe an irregularity in the endoscopic co2 regulation unit, immediately stop using the endoscopic regulation unit and withdraw the endoscope from the patient slowly as described in the endoscope¿s instruction manual.

Event Description

Olympus was informed that the patient¿s cecum was perforated during a colonoscopy procedure.The patient had two polyps removed using an olympus colonoscope (cf-hq190l), co2 regulation unit (ucr) and a non-olympus hot snare.However, following the procedure the patient complained of abdominal pain.No additional procedures were performed for the perforation; however, the patient did experience a longer stay for iv antibiotics, pain medication and imaging studies that revealed free air in the abdomen.The patient had a follow-up visit with the doctor on (b)(6) 2017 and the patient is doing well.The user facility reported it was a difficult procedure due to restricted mobility inside the patient¿s colon and they are unsure which device caused or contributed to the perforation.1of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information provided by the original equipment manufacturer (oem).No device has not been returned to olympus for evaluation to date.The oem performed an investigation based on the available information.The oem conducted a review of the device history records (dhr) for the concern serial number and found no abnormalities during the manufacturing process.The complaints records were reviewed with no similar events related to the reported event and reported device.The device was sold in december 27, 2012 with no service records.Based on reported information, there is a high possibility that the perforation to the patient¿s colon was caused by the operator¿s technique and not caused by the ucr device.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fcx to hif.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: ENDOSCOPIC CO2 REGULATION UNIT
• 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 ; 408935-512
• MDR Report Key: 7083483
• MDR Text Key: 93819894
• Report Number: 2951238-2017-00754
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: UCR
• Device Catalogue Number: UCR
• Device Lot Number: N/A
• Other Device ID Number: 04953170239113
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 04/20/2018; 02/20/2019
• Supplement Dates FDA Received: 04/26/2018; 03/18/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR