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

Model Number	CNS155
Medical Device Problem Codes	Melted (1385); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Swelling/ Edema (4577)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
An olympus representative reported on behalf of the customer that the patient developed edema and granulation possibly related to the chitozolve finished good (8/pk) intranasal splint.These were noted during management of the patient following an unspecified surgery.The device was used therapeutically to separate tissue or structures compromised by surgical trauma, to help control minimal bleeding following surgery or trauma, and to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity.However, the device reportedly did not adequately separate the tissues compromised by surgical trauma and did not aid in natural wound healing due to unclear reasons.It also did not prevent adhesions in the nasal cavity as the device dissolved too fast and did not remain where placed.The patient had a third-party nasal packing placed and also underwent sharp dissection of the adhesions.There was no further patient impact reported.
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, a definitive root cause could not be determined.The subject device was not returned for evaluation, and insufficient information regarding the event was provided.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: 17611778
• Report Number: 3003790304-2023-00331
• Device Sequence Number: 12612297
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 11/30/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 12/05/2023
• 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: Female