MAUDE Adverse Event Report: GYRUS ACMI INC INSTACLEAR SHEATH, OLYMPUS 30D, 4K TOP; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number	LCS4K30TPOL
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was received and evaluated.Evaluation noted that the sheath was observed to have a piece broken off from the distal end with sharp edges confirming the reported customer complaint.The broken off metal piece is the vertical wall of the sheath.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Reported issue was confirmed.The exact root cause of this failure mode could not be determined from the failure mode.However, per review of the shipment record , the instaclear sheath undergoes a visual inspection to ensure that the intact sheath is safely packaged and secured for package integrity.It is likely that the device left the facility free from damages.This suggests that the damage to the device may have incurred as a result of transportation or use.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that during preparation for use when placing the sheath above the optic in the sterile field of the unit, a metal part was released and the end of the sheath was observed with a cutting edge.Device was replaced.There was no patient involvement on this event.No user injury reported.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 30D, 4K TOP
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10874805
• Report Number: 1037007-2020-00091
• Device Sequence Number: 14266494
• Product Code: EOB
• UDI-Device Identifier: 00821925041400
• UDI-Public: (01)00821925041400
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K152531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: No Information
• Device Model Number: LCS4K30TPOL
• Device Lot Number: JC735701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1