MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number HX-202UR

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Clip quickclip pro 230cm 10/bx hx-202ura.The clip would not come out of sheath.The sheath was advanced out of the scope and the clip was obscured in the view of the scope.When the field cleared the clip was not visualized after advancing the clip holder.No clip was visualized inside the patient via the scope.Six other clips of a different manufacturer were used successfully: they were deployed at the appropriate site and visualized after placement.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 16085622
• MDR Text Key: 306505739
• Report Number: 16085622
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female