MAUDE Adverse Event Report: GYRUS ACMI, INC INSTACLEAR SHEATH, OLYMPUS 70 DEGREE SCOPE, BTM CABLE

Model Number	LCS4K30BTOL
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was received and evaluated at olympus (b)(4).Visual inspection was performed and actual product was noted to be in a damaged state.Device evaluation confirmed that the stopper at the tip of the sheath was found deformed.The device history records for this product have been reviewed.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.As the actual product is clearly in a damaged state and is at a level detected by inspection at the time of shipment, it is considered unlikely that it was damaged from the time of shipment.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that during preparation for use for a functional endoscopic sinus surgery (fess) procedure, the user opened the lcs4k30bto device and found that the stopper at the tip of the shaft was found rolled up,deformed.The device was replaced with similar device and the intended procedure was completed.No patient harm or impact was reported.No user injury reported.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 70 DEGREE SCOPE, BTM CABLE
• Common Device Name: INSTACLEAR SHEATH, OLYMPUS 70 DEGREE SCOPE, BTM CABLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10887033
• Report Number: 1037007-2020-00094
• Device Sequence Number: 3254171
• Product Code: EQJ
• UDI-Device Identifier: 00821925041417
• UDI-Public: (01)00821925041417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: LCS4K30BTOL
• Device Lot Number: SM902807
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1