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

Model Number FG-22Q-1

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  Injury  

Event Description

The customer reported to olympus, during a therapeutic stone retrieval, the stone was grasped but the physician was unable to retrieve the stone or release the stone.The stone was stuck.The physician did not have the emergency device bml-110a-1 available at this time to cut the basket.The physician stated he was having the patient transferred to another facility to safely remove the basket.Attempts to retrieve additional information have been unsuccessful.No additional information available.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2022-00376.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's investigation.New information added to the following fields: the device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer reported the probable cause could be: ·lithotomy procedure was repeatedly performed causing deformation of the grasping section.·grasping section was holding a larger calculus than opening of the duodenal papilla.The instructions for use include the following warning: do not use this instrument for a calculus that is assumed impossible to be retrieved by this instrument in preoperative diagnosis, intraoperative contrast enhancing or after papillotomy/ papillary dilation.Do not use this instrument when it is inevitable to grasp many calculus at a time.The basket with calculus engaged may not be removed from the body.·use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case this instrument with calculus engaged may not be removed from the body, or in case the calculus cannot be crushed even the lithotriptor bml-110a-1 is used in combination.·never use excessive force to open or close the grasping basket.This could damage the instrument.·when the basket does not open and/or close smoothly, do not apply force but move the forceps elevator, set the scope¿s angle back, or move the position of the basket until the basket opens and closes smoothly.If the action is forced, the tube may stretch and the resistance of the handle may increase.Also the calculus may not be retrieved, and/or the basket with calculus engaged may not be removed from the body.·this instrument will deform and/or deteriorate by performing calculus retrieval.Repetition of calculus retrieval will extend the effect.By such deformation and/or deterioration, calculus may not be retrieved and/or the basket with calculus engaged may not be removed from the body.If calculus retrieval needs to be repeated in a single case, make sure to check the action and the appearance each time that no abnormality is detected (e.G.Basket wire cut or worn, tube sheath bent etc.).Stop use when any abnormality is detected.

• 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: 14084280
• MDR Text Key: 294606800
• Report Number: 8010047-2022-06120
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 04953170031991
• UDI-Public: 04953170031991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-22Q-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other