MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GRASPING FORCEPS

Model Number FG-53SX-1

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed, the jaws did not open when the slider was operated.A brown foreign substance had adhered to the link mechanism of the jaws.Buckling was observed in the insertion portion at approximately 400mm, 470mm, and 560mm from the distal end.After the foreign substance removing and applying the lubricant, the jaws were able to operate smoothly.There were no missing parts in the subject device.The manufacturing record was reviewed and found no irregularities.It is presumed that the event was caused by the combination of foreign matter adhesion and insufficient lubrication application.It is presumed that the adhesion of foreign matter is due to insufficient cleaning, or that it has not been sufficiently cleaned due to the passage of time after use.The above device handling has warned in the instruction manual as follows."reprocess the instrument immediately after use, first by immersing it in a neutral, low-foaming, medical grade detergent solution, then following the cleaning and sterilization procedures given in this chapter.Failure to reprocess the instrument immediately after use, or using other than a medical-grade detergent may cause corrosion at the metal parts like the grasping jaws.This could impair the operation of the instrument or cause a part of it to break and/or fall off inside the patient.".

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that during inspection of the subject device before use, the jaws did not open.The jaws was less than a year after purchase.The intended procedure was completed with another device.There was no patient injury reported.The subject device was returned to olympus for evaluation.On (b)(6) 2021, olympus medical systems corp.(omsc) found that the jaws did not open, and that a brown foreign substance had adhered to the link mechanism of the device tip.

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• 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: 13234393
• MDR Text Key: 289348462
• Report Number: 8010047-2022-01295
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FG-53SX-1
• Device Lot Number: K0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1