MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II COLONOVIDEOSCOPE

Model Number	CF-H180DL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	05/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The referenced device was returned to olympus and is pending evaluation.The cause of the reported event cannot be determined at this time.However, the cf-h180dl instruction manual warns users¿ regardless of the flexibility of the endoscope¿s insertion section, it can cause patient injury, bleeding, and/or perforation if it is forcibly inserted, withdrawn, and/or twisted with excessive force.
Event or Problem Description
Olympus was informed that during an unspecified procedure, a patient's colon was perforated.It was reported that the patient is very slim and the event occurred during the scope's ascension up the colon.There was no bleeding observed.An x-ray was performed.The patient was sent to the or and underwent a laparotomy to close the perforation.The intended procedure was aborted.The patient was admitted to the hospital and discharged five days post op.In addition, the user facility reported that there was no malfunction noted with the device during or post procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found no signs of any abnormalities with bending section movement and the up/down/right/left angulations on the scope.No anomalies were found with the variable stiffness function and control knobs movements.The distal end cover, nozzle, bending section cover glue and channel opening were also inspected and there were sharp areas noted on the surfaces.Additionally, the biopsy channel was inspected with an olympus boroscope and no signs of foreign objects/materials or missing parts were noted.However, the evaluation found a sharp surface on the bending section cover glue at the insertion tube side.A cotton test was performed on the bending section cover glue (insertion tube side) and catching was noted due to cracks and lifting on the cement/glue.The bending section cover glue was noted to be discolored.Based on the evaluation results, there were no signs of stiffness or abnormal shape with the bending section or insertion tube that would have attributed to the user¿s complaint.The cause of the cracks and discoloration on the bending section cover glue is due to the chemical damage.The instruction manual warns users ¿after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual.Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.¿.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7623737
• Report Number: 2951238-2018-00357
• Device Sequence Number: 19349604
• Product Code: FDF
• UDI-Device Identifier: 04953170339653
• UDI-Public: 04953170339653
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CF-H180DL
• Device Catalogue Number: CF-H180DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR