MAUDE Adverse Event Report: GYRUS ACMI, INC BLADE NOSECONE ADAPTOR GRIP

Model Number	NCGRIP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject has not yet been received for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that black stains were found when opening the device package.The device was replaced and another one of the same product was used.The issue was found in preparation for a therapeutic procedure.There is no patient involvement associated on this event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.At the time of equipment evaluation, no stains were found on the device or sterility pack.The phenomenon may not be reproduced because the sterilization process was performed at the time of return, but since there is no evidence of dirt on both the device and the sterilization pack, it is possible that the event that occurred at the facility adhered after removal.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of stains on device or sterility pack could not be confirmed.However, it is noted per the dhr that a total quantity of 50 units were properly sterilized without and any rejected or scrapped.It is unlikely for the damages discovered to have occurred in the manufacturing site.Therefore, damages incurred may have been as a result of device transportation or customer use.Olympus will continue to monitor field performance for this device.

• Brand Name: BLADE NOSECONE ADAPTOR GRIP
• Common Device Name: BLADE NOSECONE ADAPTOR GRIP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 13563587
• Report Number: 1037007-2022-00004
• Device Sequence Number: 19947715
• Product Code: GEI
• UDI-Device Identifier: 00821925040694
• UDI-Public: 00821925040694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: Health Professional
• Device Model Number: NCGRIP
• Device Lot Number: AV105616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown