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 Codes	Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received information from a post-market clinical follow-up (pmcf) survey that the chitozolve finished good (8/pk) was used and soft tissue trauma, granulation, and edema all occurred and were possibly device related.Moderate and hard to detach adhesions also formed in the nasal cavity requiring blunt dissection, however these adhesions were due to patient factors and unrelated to the device.This lead to further management of the patient following surgery.The intended procedure was therapeutic and was completed with the same device.No other devices were involved in the event.The chitozolve splint adequately separated tissue compromised by the surgical trauma.The device helped control minimal bleeding following surgery/trauma and helped in natural wound healing.The device was dissolved completely at the time of 20-day follow-up.
Additional Manufacturer Narrative
A2: specific age not provided, however the age range provided was between 18 years to 34 years.E2: inadvertently selected no radio button, but unable to remove selection.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.
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.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: 17653473
• Report Number: 3003790304-2023-00342
• Device Sequence Number: 17706423
• 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: Study,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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
• Is the Reporter a Health Professional?: 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 Sex: Male