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

Model Number	FG-44NR-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2020
Type of Reportable Event	Malfunction
Additional 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.Omsc checked the attached photo and confirmed that one of the arms of the grasping jaws was broken off and missing about 1 mm.There was pitting corrosion around the broken part.The manufacturing record was reviewed and found no irregularities.Based on the investigation result, omsc presumes that the event occurred due to the following mechanism.The cleaning of the device after use was insufficient and foreign materials and/or detergent solution were remained.The residue corroded the arm and weakened it.The weakened arm broke off while moving the grasping jaws.The above device handling has warned in the instruction manual as follows.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 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.
Event or Problem Description
It was reported that fault was found at distal end of the subject device and the part broke outside the patient during an inspection before use.The intended procedure was completed with another device.There was no patient injury reported.On (b)(6) 2020, olympus medical systems corp.(omsc) found that the arm of the grasping jaws was partially missing.

• Brand Name: ROTATABLE GRASPING FORCEPS
• Common Device Name: ROTATABLE GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10512474
• Report Number: 8010047-2020-06360
• Device Sequence Number: 2682313
• Product Code: EOQ
• UDI-Device Identifier: 04953170032196
• UDI-Public: 04953170032196
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: No Information
• Device Model Number: FG-44NR-1
• Device Lot Number: 99K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1