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

Model Number FG-49L-1

Device Problems Flushing Problem (1252); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned with three sterile packages to olympus medical systems corp.(omsc) for evaluation.The returned sterile packages were checked.As it was pointed out, a brown stain was confirmed on three packages.No abnormalities such as foreign material adhesion around the grasping section and the reprocessing port were observed.The subject device was checked.Investigation was carried out by running water through the reprocessing port using a syringe.No foreign materials related to the reported phenomenon came out of the reprocessing port.No defects such as missing parts were confirmed.Also, no abnormalities that could lead to the health hazard were observed.The manufacturing record was reviewed and found no irregularities.The complaint occurrence that is the same phenomenon as the reported event or similar phenomenon to the reported event that related to the product family for over the past year was inspected.One report was confirmed at another facility.There were no reports of the occurrence of the complaint on the same device at the same facility that is the same as the reported event or similar to the reported event.Since no abnormalities that could lead to the reported event were detected, the exact cause of the reported event could not be determined.Since the component analysis was performed in past similar cases and chemical solutions and cleaning solutions were detected in the foreign materials, omsc presumes that the event occurred due to the following occurrence mechanism.Due to insufficient cleaning, liquid such as cleaning solutions or chemical solutions remained in the insertion portion.Liquid that remained inside of the insertion portion was coming out from the distal end of the insertion portion.This caused a stain adhesion.During autoclaving, the adhered liquid dried out by heat.

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that after reprocessing the subject device, the following event occurred.When the customer checked the device inside the sterile package, brown stains of 1 cm square exuded from the tip of the grasping section, and the sterile package turned brown around there.A similar event occurred even after reprocessing repeated.It also occurred on the device that is not used for a patient.There is no patient injury reported currently.The brown stains were not in contact with the facility staff's skin since the staff wore protective equipment.

• 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: 11683698
• MDR Text Key: 269808484
• Report Number: 8010047-2021-05067
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FG-49L-1
• Device Lot Number: K1127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1