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

Model Number LCS4K30BTOL

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

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 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
• Type of Device: INSTACLEAR SHEATH, OLYMPUS 70 DEGREE SCOPE, BTM CABLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 10887033
• MDR Text Key: 228231154
• Report Number: 1037007-2020-00094
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00821925041417
• UDI-Public: (01)00821925041417
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LCS4K30BTOL
• Device Lot Number: SM902807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1