MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. GRASPING FORCEPS

Model Number FG-50L-1

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

E1: complete establishment name: (b)(6).To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The user facility reported to olympus that during endoscopic mucosal resection (emr) surgery, the gastric wall was perforated by a non-olympus device.At the same time, when this grasping forceps was used to remove the cut tissue, the forceps jaw was disconnected and the forceps jaw fell off and fell through the perforation into the patient's abdomen.The patient was subsequently transferred to laparoscopic surgery, on the same day, to remove the fallen part.The patient's life, as reported, is not in danger after surgery.The device was inspected before use and showed that the opening and closing were normal.High temperature autoclave sterilization was used after cleaning.The intended emr surgery was completed by using the same set of equipment.There was no delay in emr surgery, but there was delay in dealing with piercings.The patient was under anesthesia at the time of the malfunction.The physician would not say how long the patient had been under anesthesia.There were no reports of further patient or user harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the forcep jaw/component falling off into the patient was likely caused by the following mechanism: 1.Insufficient cleaning of the device after use left foreign material and/or detergent solution on the arm of the grasping jaws.2.The residue corroded the arm and weakened it.3.The weakened arm broke off when a force was applied to it during handling.Therefore, one of the grasping jaws fell off inside the body.Furthermore, the patient was transferred to laparoscopic surgery to remove the fallen part from the body.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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 something 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.¿ this supplemental report includes information added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16729104
• MDR Text Key: 313191020
• Report Number: 9614641-2023-00515
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04953170032448
• UDI-Public: 04953170032448
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-50L-1
• Device Lot Number: K5218-0681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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
• Treatment: GIF-Q260J UNKNOWN SERIAL NUMBER.
• Patient Outcome(s): Required Intervention