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

Model Number UCR

Device Problem Improper Flow or Infusion (2954)

Patient Problem Injury (2348)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, an olympus sales representative contacted the customer to inquire about the inspection and pretest of the equipment prior to use and was informed that the ¿¿pre-procedure¿¿ verification of the air/water function was performed using sterile water to see if bubbles were coming out of the air water nozzle and verified the suction function of the device.However, the valves were not physically inspected for any default or residues.The device was not returned to olympus for evaluation.The exact cause of the reported event could not be determined at this time.The instruction manual for the ucr warns ¿during use, always stop the device and light source from supplying air.If stop is not selected, a mixture of air and co2 may be supplied into the patient body.Make sure that the adapter biopsy valve, the needle adjuster, the stopper, the connector section, and the connecting slider are not damaged.¿ in addition, the instruction manual for the clv-190 (section 5.9) light source that is used with the ucr 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 colonoscopy, while introducing the endoscope towards the caecum, the surgeon visualized the presence of hematomas and stripes on the walls on the intestine, prompting the surgeon to immediately abort the procedure and withdraw the endoscope.The patient was sent to the radiology department for a ct scan which showed¿¿free air¿¿ in the patient's intestine.The patient was hospitalized for a few days for observation and was "treatment" with antibiotics.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found a small dent on the rear corner of the top cover and a missing screw.The internal parts were found to be in good condition and intact.The device was connected to the test co2 gas cylinder via a regulator.The device passed all the implemented inspection items, and the measurable inspection results are within the specification.Based on the evaluation findings, the reported complaint was not confirmed.The device passed all functional inspection and works as designed.Additionally, the original equipment manufacturer (oem) performed a review of the investigation findings and reported that a root cause could not be determined as the device functioned as intended.The oem performed a review of the dhr for the device model/serial number and found no abnormalities during the manufacturing of this device.In effort to mitigate patient injury the oem referenced the following ifu statements: when the endoscopic co2 regulation unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components.Such contact may cause unintended current flow to the patient.If the insufflator emits a caution (caution light or alarm) for cavity over-pressurization, quickly open the stopcock or valve of the trocar.Then, reduce the amount of outflow from the laser device, argon-enhanced coagulator, or other gas supply device.If use is continued while the alarm sounds, there is a risk of gas embolism due to cavity over-pressurization.Be careful not to feed co2 too much during co2 gas feed or spraying.Excessive co2 gas feed/spraying may cause pain to the patient and/or gas embolism.Reduce the use of co2 gas feed and spraying at the requisite minimum level.In case the insufflator is used in operation, open the trocar cannula stopcock if the pressure in the abdomen exceeds the set pressure by more than 5 mmhg.Do not attempt to insufflate the abdominal cavity using the lens cleaning sheath.Otherwise, patient injury and/or gas embolism may result.Do not use the endoscopic co2 regulation unit in combination with other than the compatible lens cleaning sheath (with the maj-1345, maj-1537, or maj-659, for example).Otherwise, co2 gas is fed continuously and patient pain and gas embolism can result.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8192598
• MDR Text Key: 131319159
• Report Number: 2951238-2018-00804
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UCR
• Device Catalogue Number: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CV-190/SN. (B)(4) AND CLV-190/SN. (B)(4); SCOPE MODEL: CF-H180/SN. UNK
• Patient Outcome(s): Hospitalization; Required Intervention