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

Model Number	CNS155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A post market clinical follow-up survey was completed by an unidentified customer in which a patient was being managed postoperatively using the chitozolve intranasal splint.This was being used to for after nasal surgery to separate tissue/structures compromised by the surgical trauma, help control minimal bleeding following surgery, and separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity.The splint was unable to stop the minimal bleeding postoperatively after having technical issues.It was clarified that the technical issues were due to the splint being hydrated with pharmaceutical agents.A nasal cautery had to be used to prevent further blood loss.It was stated that the treatment did prevent nasal cavity adhesions and it also aided in natural wound healing in this patient.There was no additional notation of impact to the patient or treatment required.
Additional Manufacturer Narrative
A2: clarification.The age of the patient was stated to be in the range of 18-34 years.E2: the radio selection of no was inadvertently selected and cannot be unselected.The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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/lot 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, since the device was not returned for evaluation, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "help control minimal bleeding.And¿in the case of prolonged bleeding seek medical attention." this supplemental report includes a correction to e1 and e3 to provide information that was inadvertently not included in the initial medwatch.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: 17652669
• Report Number: 3003790304-2023-00341
• Device Sequence Number: 15329075
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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?: No
• 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: 08/30/2023
• Supplement Report FDA Received Date: 10/19/2023
• 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 Age: 18 YR
• Patient Sex: Male