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

Model Number CF-HQ190L

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found 1cm of the scope¿s bending section cover is torn off and missing.The missing bending section cover was not returned.The bending section is detached from the insertion tube side causing the elements inside to be exposed.The screw that holds the bending section together is missing which attributed to the detachment of the bending section.The bending section screw hole was noted to be stripped.There were non-olympus repairs identified with the distal end c-cover, bending section cover, bending section cover glue, objective lens glue and light guide lens glue, which most likely caused the torn bending section cover and detached bending section.The instruction manual states ¿before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient.As repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage, be sure to contact olympus for repair.¿.

Event Description

Olympus was informed that during a diagnostic colonoscopy the doctor noticed minor bleeding near the proximal sigmoid.The scope was partially withdrawn several centimeters and the doctor observed that the patient¿s mucosa was lacerated in three areas.The doctor stopped the procedure and upon completely withdrawing the scope, the doctor observed its bending section was torn open with exposed metal coils.No sharp instruments were inserted into the scope at any point of the procedure.The patient did not require any additional treatment or hospitalization.The intended procedure was completed with a similar device.In addition, it is unknown if the scope was inspected prior to use.The user facility reported that the scope¿s care includes cleaning and disinfection with steris preprocessor and prolystica chemical solution.Performing pre-cleaning immediately after the procedure and in accordance to the ifu.Also, performing leak testing prior to manual cleaning.The scope is stored in a cabinet after reprocessing.Reportedly, all of the user facility¿s reprocessing personnel is trained on how to properly reprocess an endoscope.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Additional information received for a previously reported event states that small black fragments from the scope were observed prior to withdrawing the broken scope.In addition, after the lacerations and bleeding was observed the patient was transferred to recovery and placed on clear liquids.A x-ray was performed and the patient was negative for a perforation.

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8438810
• MDR Text Key: 139418528
• Report Number: 2951238-2019-00562
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (y/n): N
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR