MAUDE Adverse Event Report: GYRUS ACMI, INC INSTACLEAR SHEATH, OLYMPUS 0° 4K ULTRA SCOPE, UNIV POSITION

Model Number LCS4K00UNOL

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility returned (to (b)(4) facility) the referenced instaclear sheath.A provisional evaluation observed the post at the end of the distal tip was broken.A visual inspection found that the pin that serves as a stopper to prevent the scope from sticking out at the tip of the sheath was removed.Since there were traces of laser welding on the part where the stopper pin was attached and the peripheral part was slightly deformed, it would suggest that the pin was attached at the time of shipping, but it was strongly pushed when inserting the scope etc.It is probable that the pin has come off due to the overload of force.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

During an unspecified procedure the physician attempted to connect the instaclear sheath to the 4mm 0 degree optical tube, however, the tip stopper was not attached.The problem occurred with two instaclear sheaths.The intended procedure was completed using a third instaclear sheath.There was no patient injury reported.This report is for device 1 of 2.

Manufacturer Narrative

The device will not be returned to the manufacturer.A replacement device has been provided to the (japan) customer.In addition, the manufacturer was unable to conduct a review of the device history records (dhr) due to no available lot number.However, based on the investigations the potential cause of the reported pin coming off was due to overload from stress/force.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 0° 4K ULTRA SCOPE, UNIV POSITION
• Type of Device: INSTACLEAR SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10171780
• MDR Text Key: 196907396
• Report Number: 1037007-2020-00011
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K152531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LCS4K00UNOL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1