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

Model Number FG-51D

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that during the procedure of the bronchus using the subject device, the following event occurred.The device was not able to retract into the endoscope.The patient had to be transferred to another hospital.On june 1, 2021, the following additional information was provided.*the health professional tried to extract the tooth in the bronchus with the device but it failed, so tried with another device, but it failed again.*the procedure was extended by 30 minutes.*in the transferred hospital the tooth was successfully retrieved from the bronchus.*the patient is in a good general state of health after an extended hospitalization.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.This event has already occurred in the past.Based on the result of a previous similar complaint investigation, it is possible to predict the cause of the reported event.Therefore, it was determined that the investigation by using equipments of similar structure or similar equipments was not necessary.It can be inferred that the tube might have been compressively buckled.This might have caused the grasping portion not to close.Based on the similar investigation results in the past, a likely mechanism causing the reported event might be the following.1.The endoscope was excessively angulated.Or the tube which comes out from the endoscope biopsy valve was bent.2.Operating the ring in the above situation have caused the tube and operation wire to increase the sliding resistance.That have caused the tube compressively buckled.3.Due to "2", the operating portion could not work well.Repeatedly operating the ring might have made the compressively buckled tube to stretch and tear.The above device handling has warned in the instruction manual as follows.*do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.*never use excessive force to open or close the grasping portion.This could damage the instrument.

Manufacturer Narrative

This supplemental report is being submitted to withdraw mfr report #8010047-2021-07467.Olympus concluded that there was no mdr reportable malfunction or adverse event.

• 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 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: 11989737
• MDR Text Key: 255929198
• Report Number: 8010047-2021-07467
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FG-51D
• Device Lot Number: 03K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1