MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S190-10

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was tested and visually inspected, results identified a leak/cut during leak testing and a cut was observed on the video cable during visual inspection.Visual inspection also revealed peeling of the adhesive on the lens.The results revealed that the verified issues were traced to wear and tear.

Event Description

The customer reported that the device failed air/water leakage test.There was no report of patient involvement and no additional information was received.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reported that the most probable causes for the reported event are as follows: it was presumed the cause the glue peeled off as impact by hit/dropped the device and/or deterioration of the glue due to sterilization by sterrad nx.Ifu operation manual warns about adding stress to distal end as follows.The case may have had deviation from ifu operation manual.Important information: please read before use : contraindications, warnings, and cautions : do not strike, hit, or drop the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connector, or light guide connector 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.Moreover, ifu reprocessing manual alerts on sterilization by sterrad nx that though it is applicable, it may deteriorate the adhesive of the insertion section.3.1 compatibility summary : list of compatible methods validated in terms of material durability : sterrad® nx¿ : sterilization by sterrad® nx¿ system may deteriorate the adhesive of the insertion section.Depending on the circumstances, replacement of the insertion section may be required.Before use, confirm that the endoscope is free from any damage or other irregularities.For further details, contact olympus.In addition, as a result of dhr review, it was confirmed that the product was shipped in a condition where the specifications were met.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10134712
• MDR Text Key: 223218592
• Report Number: 8010047-2020-03236
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1