MAUDE Adverse Event Report: ANNEX MEDICAL, INC. 4-PRONG GRASPING FORCEP,5FR,58CM

Model Number	GF-558
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.This report will be supplemented accordingly following investigations.
Event or Problem Description
The user facility reported that prior to processing, the equipment was found broken.The user opened the package and noticed that the grasper was broken.The issue occurred prior to a stent removal procedure.The same device was not used to complete the procedure.No patient injury or harm was reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device was returned to olympus for evaluation.Upon evaluation of the device damage was able to be confirmed.The inner sheath was kinked and prevented the grasper from being fully closed.The device was returned to the oem (original equipment manufacturer) for further evaluation.The oem confirmed the damage and the damage is consistent with device reuse and reprocessing.The true lot number was not provided, the date code on the device is eb.This device was manufactured in may 2018, which is lot number 40246 or 40247.The oem performed a dhr (device history record) review on the two possible affected lots and the inspection results met the acceptance criteria and no unusual results or defects were noted.Olympus will continue to monitor the field performance of this device.

• Brand Name: 4-PRONG GRASPING FORCEP,5FR,58CM
• Common Device Name: 4-PRONG GRASPING FORCEP,5FR,58CM
• Manufacturer (Section D): ANNEX MEDICAL, INC.; 6018 blue circle drive; minnetonka MN 55343
• MDR Report Key: 12070622
• Report Number: 3003790304-2021-00117
• Device Sequence Number: 3782192
• Product Code: GEN
• UDI-Device Identifier: 00821925002432
• UDI-Public: 00821925002432
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT-GEN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: Health Professional
• Device Model Number: GF-558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1