MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/20/2021

Event Type  Injury  

Event Description

It has been reported a single use ligation device was used for colonoscopy procedure, polyp removal.The user successfully removed the polyp and placed hemostatic clips to the area.The patient was discharged home.An unknown time later the patient returned to the facility with reports of ¿oozing¿ (blood) from the area the polyp was removed.It the user reports 2 caps (rod) broke off during the procedure, stating "the rod inside the handle of the device snapped while the wire was looped around the polyp area".The wire was removed by pulling and tugging on the wire.After the wire was removed, bleeding was noted.Three additional hemostatic clips were placed to stop the bleeding.Additional details have been requested regarding the patient and reported event, at this time, no additional information has been provided.This is report 2 of 2.Related report with patient identifier (b)(6).

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12022801
• MDR Text Key: 257177109
• Report Number: 2951238-2021-00349
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021,06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention