MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MAF-GM (D); AIRWAY MOBILESCOPE

Model Number MAF-GM

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at this time.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.If additional information is received, this report will be supplemented.

Event Description

Olympus was informed that a part of the bending section rubber of the subject device fell off during an unspecified procedure and the start time of the procedure was delayed about two hours.The facility replaced the subject device with another scope and completed the procedure.There was no information on whether a part of the bending section rubber of the subject device fell off within the patient or not, but there was no report of patient injury associated with this report the facility reported that they used narrower sheath than usual with the subject device during the procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result of the subject device.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation, it was confirmed that there were scratches and chips on the bending section rubber and the adhesive.There was no other abnormaly in the subject device.The exact cause of the reported event in which the bending section rubber had fallen off could not be identified.From similar cases in the past, the abnormalities were surmised to have occurred due to excessive mechanical stresses.The operation manual has already warned; ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, or camera section.Also, do not bend, pull, or twist the endoscope¿sdistal end, insertion tube, bending section, control section, or camera section with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.If additional information is received, this report will be supplemented.¿ if additional information becomes available at a later time, this report will be supplemented.

• Brand Name: MAF-GM (D)
• Type of Device: AIRWAY MOBILESCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7198481
• MDR Text Key: 97783056
• Report Number: 8010047-2018-00067
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAF-GM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Date Manufacturer Received: 01/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1