MAUDE Adverse Event Report: GYRUS ACMI, INC. CHITOZOLVE FINISHED GOOD (8/PK); SPLINT, INTRANASAL SEPTAL

Model Number	CNS155
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not being returned for analysis.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Olympus received information from a post-market clinical follow-up survey that the chitozolve finished good (8/pk) was used for a therapeutic procedure and prolonged bleeding occurred which required management of the patient with post-surgical epistaxis.The chitozolve splint did not stop bleeding upon insertion into the patient due to technical issues and did not remain where it was placed.The device was being used as a nasal hemostat to treat epistaxis and the procedure was not completed.There were no other devices involved in the event or replaced during the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a specific root cause could not to be determined for the suggested event.The device was not returned and there is not enough information to determine a root cause.The event can be prevented by following the instructions for use which state: ""help control minimal bleeding."" and ""in the case of prolonged bleeding seek medical attention."" olympus will continue to monitor field performance for this device.

• Brand Name: CHITOZOLVE FINISHED GOOD (8/PK)
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17643613
• Report Number: 3003790304-2023-00338
• Device Sequence Number: 8059632
• Product Code: LYA
• UDI-Device Identifier: 00821925044166
• UDI-Public: 00821925044166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNS155
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male