MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA LAPARO-THORACO VIDEOSCOPE

Model Number LTF-VP

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject ltf-vp returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the reported abnormality of the subject device.And there were scratches on the bending section of the subject device.From the above, omsc surmised that this phenomenon was caused by the contact between the subject device and a trocar or other device.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The instruction manual provides of the device provides warnings and how to inspect the device prior to use as follows.Warning: confirm that the trocar end does not have a burr that could cause damage to the bending section of the endoscope.Insert /withdraw the endoscope into/from a trocar slowly and deliberately while viewing the endoscopic image, after the bending section is straightened by moving the angulation lock in the ¿f ¿ direction until it stops, and moving the angulation control lever back to the neutral position.Until the endoscope is completely withdrawn from the trocar, pull it out in straight.If a trocar with a valve is used, keep the valve open during insertion and withdrawal.Failure to do so may result in the breakage of the endoscope.If resistance is felt and the hand instrument is difficult to insert, withdraw the hand instrument and the endoscope, and inspect the covering of the bending section for sagging, cuts, holes, or other irregularities.The irregularity could cause parts of the covering to fall of inside the patient.When moving and/or rotating the bending section, confirm the indexes of insertion length.If the bending section contacts at the edge of the trocar tube, damage to the bending section may result.Inspection.Inspect the covering of the bending section for sagging, swelling, cuts, holes, or other irregularities.

Event Description

During an unspecified procedure with the ltf-vp, the covering of the bending section of the subject ltf-vp broke.The user replaced the subject ltf-vp to another unspecified device to complete the procedure.There was no report of the patient injury other than replacing the device.

• Brand Name: VISERA LAPARO-THORACO VIDEOSCOPE
• Type of Device: LAPARO-THORACO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8766906
• MDR Text Key: 150556202
• Report Number: 8010047-2019-02429
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-VP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1