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

Model Number	LCS1870BTST
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, foreign matter (like a wood chips) found inside the sterility pack.The device was replaced using the same type of device.The issue was found at preparation for use.There is no patient involvement associated on this reported event.
Additional Manufacturer Narrative
The customer returned a lcs1870btst and reported foreign material like wood chips found in the sterility pack.The olympus service team received a lcs1870btst for the reported issue of foreign material like wood chips found in sterility pack.The user request was able to be confirmed as woodchips were observed within the packaging when received.The dhrs (device history records) review 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.Review of lot showed no associated ncrs (nonconformance's reports), reported scrap, or recorded process deviations relating to the reported failure.The definitive root cause of the instaclear sheathe having wood chips within the sterility pack could not be confirmed.However, per component characterization form review, the lot undergoes inspection to compare the finished good with the sample good.Moreover, per instaclear sheathe packaging sequence, it is noted that in the visual inspection of the pre-seal pouch, the acceptance criteria includes package integrity and foreign material inspection.If foreign materials were introduced into the packaging, it was likely due to device transportation or customer storage/use.Olympus will continue to monitor complaints for this device.

• Brand Name: INSTACLEAR SHEATH, STORZ 70 DEGREE SCOPE, BTM CABLE
• Common Device Name: INSTACLEAR SHEATH, STORZ 70 DEGREE SCOPE, BTM CABLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13246908
• Report Number: 8010047-2022-01381
• Device Sequence Number: 19982068
• Product Code: EOB
• UDI-Device Identifier: 00821925039957
• UDI-Public: 00821925039957
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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: LCS1870BTST
• Device Lot Number: AV104675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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
• Patient Sex: Unknown