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

Model Number	FG-53SX-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from user facility that the subject device broke afer only 6 months of use.The subject device was returned to omsc for evaluation.The distributor confirmed the following event on (b)(6) 2021 and determined that it was an medical device report (mdr) reportable event.Part of the broken arm was missing.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed, the model name was fg-53sx-1 with lot no k05.One of the arms of the cups (a part of the linking mechanism at the distal end) was broken off.The broken arm had brown foreign material around the broken place.The broken surface indicated the break was a brittle fracture caused by corrosion.Part of the broken arm was missing.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation result.In the evaluation of olympus medical systems corp.(omsc) the following was confirmed, - one of the arms of the cups (a part of the linking mechanism at the distal end) was broken off.The broken arm had brown foreign material around the broken place.- the grasping jaw was broken at the brazing joint of the operation wire and grasping jaw.- part of the broken arm was missing.- part of the broken arm was corroded.The device history record (dhr) with the lot number of the subject device was confirmed.No abnormalities detected in the dhr for the following items which related to the reported phenomenon.-inspection omsc assumed that cups could not open and close due to the broken arm, which caused the reported unavailable of the device from the investigation result, a possible mechanism of the break is shown below.1.Insufficient cleaning of the device after use left foreign material and/or detergent solution on the arm of the cups.2.The residue corroded the arm and weakened it.3.The weakened arm broke off when a force was applied to it during handling.The above device handling has warned in the instruction manual.

• Brand Name: GRASPING FORCEPS
• Common Device Name: 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: 13040512
• Report Number: 8010047-2021-16395
• Device Sequence Number: 16608027
• Product Code: PTS
• UDI-Device Identifier: 04953170049040
• UDI-Public: 04953170049040
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K013591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: FG-53SX-1
• Device Lot Number: 05K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/19/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown