MAUDE Adverse Event Report: OLYMPUS AMERICA, INC SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/13/2022

Event Type  Injury  

Event Description

The customer reported to olympus, during a therapeutic colonoscopy with polypectomy, the clip fell apart inside the patient.The clip and spring came off of the sheath with the metal case and mucous membrane.According to the image provided by the customer, it appears as thought the clip pipe is what fell into the patient's colon and was not retrieved.There are not any plans to retrieve the device from the patient with the intention the patient would pass it (with stool).The technician who assisted with clip deployment stated, "the clip looked fine when came out the scope.Once it was positioned and closed on a defect, it made a different noise than usual and it had no tactic feel of a clip deployment, once the handle was closed all the way.Then the handle was opened and the clip came off the sheath and off the mucous.The intended procedure was completed successfully with a similar device.It is unknown if there was a procedural delay.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 15210536
• MDR Text Key: 297761351
• Report Number: 2429304-2022-00023
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/13/2022,08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 1YK 15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ENDOSCOPE
• Patient Outcome(s): Other; Required Intervention