MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number SD-400U-10

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

We received the following report.The user noticed that there was a blue thread in the sterilization pack when the user checked it during preparation for use.The user removed it and used it as it was.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report to provide additional information.The sterile package of the electrosurgical snare, subject device and packaging materials were not returned for investigation.Only one blue thread that might have been inside of the package was returned.The length of the thread was about 20 cm.The thread was not made out of silk or cotton, and it was possibly made out of twisted synthetic fibers.The manufacturing record was reviewed and found no irregularities.Production process was confirmed.However, the returned thread and non-woven fabric to cause the thread were not used during production process.Occurrence of the similar reported event in the past was investigated.No similar reports have been received over the past year.The returned thread was not used for production process.No abnormalities were detected during production process.Therefore, the exact cause of the reported event could not be identified.It can be inferred that the reported event might have occurred at the facility when the device was taken out from the package, the thread adhered due to static electricity.The instruction manual of the subject device has described pre-use inspection and what to do if there are any irregularities.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Type of Device: ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11070750
• MDR Text Key: 223630180
• Report Number: 8010047-2020-10951
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• PMA/PMN Number: K172734
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD-400U-10
• Device Lot Number: 01K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1