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

Model Number	FG-49L-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not yet received for evaluation.The exact cause of the reported event cannot be determined.A supplemental report will be filed if and when the product is returned and investigation has been completed.As a preventive measure and per the user manual under warnings : before use, confirm that the instrument is not corroded, dented or discolored, do not use it if any of these conditions are observed.If the instrument is damaged, part of it could fall off inside the patient, or it could become impossible to open or close.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.If a part of the instrument falls off inside the patient, use a spare instrument to retrieve it.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.
Event or Problem Description
During an endoscopy procedure for the removal of a foreign object (pieces of chicken), it was reported that the forceps broke inside the esophageal mucosa of the patient.Additionally, it was reported that the loose part of the forceps were recovered.There was no patient injury reported.
Event or Problem Description
Issue occurred in the beginning of the procedure.Device was inspected prior to use and no abnormalities were observed.Loose part of the forceps (grasping jaws) were retrieved using another forceps.No bleeding observed.Procedure was completed using a gastroscope.Patient is fine and no follow up check is required.

• 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
• MDR Report Key: 9161190
• Report Number: 8010047-2019-03512
• Device Sequence Number: 1971893
• Product Code: OCZ
• UDI-Device Identifier: 04953170032417
• UDI-Public: 04953170032417
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K955051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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-49L-1
• Device Lot Number: 7XK
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR