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

Model Number	PCF-H190DL
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Structural Problem (2506)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a colonoscopy, the scope bending rubber was ripped while inside the patient and the patient was injured.The scope was inside the patient's colon when the customer noticed that the scope was caught on the tissue.Customer was able to pull the scope and retract it out from the patient.There are no reports of fragments falling into the patient.The customer noticed that the bending rubber of the scope was ripped and not only was the metal mesh visible where the rubber was ripped, the customer could see the wires and channels inside the scope.Patient tissue was found in the metal mesh and torn rubber.The scope was recently sent to a third party repair company, surgical instrument service company incorporated.The patient's colon was damaged by the scope.The patient was prescribed an unspecified antibiotic and according to the user, the patient is doing well.The returned pcf-h190dl (serial# (b)(4)) was returned for evaluation.A visual inspection was performed on a received condition and determined that the bending section was separated, approximately 100 mm from the distal end side.Internal elements are preventing the bending section from becoming entirely detached from the insertion tube.The bending section separation caused rough edges and the internal elements (ccd, light guide bundle, angle wires, channels) to be exposed.No missing portions of the non-olympus bending section cover observed.Further evaluation determined that the video scope included non-olympus bending section cover, non-olympus bending section cover glue, non-olympus insertion tube, non-olympus switch buttons, and likely, non-olympus bending section.In addition, it was observed that there is heavy tension during angulation and play on the control knobs.When the image was checked, there is no picture being displayed on the monitor, and there is no switch functionality.The integrity and or durability of the non-olympus parts were not evaluated and tested however, these likely attributed to the bending section damage and they are not authorized olympus parts.Based on the device return evaluation the likely cause of the damaged bending section is due to mishandling and non-olympus parts included on the scopes.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9699365
• Report Number: 2951238-2020-00337
• Device Sequence Number: 2183220
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 02/12/2020
• Report Date (Section F): 01/17/2020

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: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2020
• 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: Other
• Patient Age: 66 YR