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

Model Number FG-53SX-1

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

During a removal of a double j catheter with the subject device, the grasping jaw of the subject device remained in open position.It was therefore not possible to remove the catheter and a new intervention was necessary 2 days later.The subject device, which grasping jaw in the open position, had to be removed in the 'open' position with the cystoscope.There was no patient injury reported except new intervention.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.When we moved the slider, the grasping jaws did not open or close.The wire inside the handle was broken off at approx 100 mm from its proximal end.The distal end of the broken wire frayed and partially extended.The wire had foreign material at the broken part.The manufacturing history record of the same lot was reviewed, with no irregularities noted.This type of event is most likely related to the operator's technique.This closing failure of the grasping jaws was caused by the broken wire inside the handle.We assumes that the wire fray occurred due to operating the subject device with excessive force in the situation where it was difficult to open or close the grasping jaws such as the insertion portion coiled into small or the endoscope angulated sharply.Operating the device continually in such condition could result in the breakage of the frayed part.The instruction manual of the device has already warned as follows; if the instrument does not operate properly during the procedure, or if it becomes difficult to open or close the grasping jaws, stop the procedure immediately and withdraw the instrument into the endoscope¿s channel.If this is not possible, carefully remove it together with the endoscope to avoid causing patient injury.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 jaws.This could damage the instrument.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6652829
• MDR Text Key: 77935370
• Report Number: 8010047-2017-00750
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK955066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-53SX-1
• Device Lot Number: K3701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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