MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)

Model Number FG-51D

Device Problem Break (1069)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The reported device was not returned to olympus for evaluation.The cause of the reported event could not be confirmed at this time.However, the instruction manual (pages 3-4) provides warning and cautions to mitigate the risk of device damage and patient injury which states: do not insert the instrument into the endoscope if the grasping portion is not completely retracted into the insertion portion.Do not advance or extend the instrument abruptly.Do not operate the slider or ring while insertion into the endoscope.The distal end of the insertion portion may extend from the distal end of the endoscope abruptly.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not push the ring and/or pull the slider abruptly.Do not force the distal end of the insertion portion against body cavity tissue.This could cause patient injury such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not withdraw the instrument from the endoscope while the grasping portion is open.This could damage the endoscope or instrument.In addition, prior to operation the instruction manual states to always have a spare instrument available.

Event Description

Olympus was informed that during a therapeutic foreign body retrieval procedure, the basket of the device broke.The intended procedure was not completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from eoq to pts.

• Brand Name: DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)
• Type of Device: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8253564
• MDR Text Key: 133521178
• Report Number: 2951238-2019-00373
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• PMA/PMN Number: K962378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-51D
• Device Lot Number: 54H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1