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

Model Number HX-20Q-1

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the subject device and found as follows; the insertion portion was severed.The loop with the ligated tissue was stuck inside the tube sheath.The tube sheath around the stuck tissue had compressive buckling.The manufacturing record was reviewed and found no irregularities.Omsc presumes that the loop could not be released since the user ligated polyp while the coil sheath was not extended from the tube sheath, and then the ligated polyp with the loop was pulled inside the tube sheath and was stuck.The above device handling has warned in the instruction manual as follows.When removing the hook from the loop, confirm on the endoscopic image that the coil sheath is extended from the tube sheath.Otherwise, the loop may get stuck inside the instrument.Do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.

Event Description

During a procedure, the subject device was used.The user could not withdraw the subject device from the patient.The user severed the insertion portion of the subject device.The user withdrew the endoscope from the patient while leaving the subject device inside the patient.The user inserted the endoscope into the patient again, resected polyp which the subject device was ligating with a snare loop, and withdrew the subject device.There was no patient injury reported although the hospitalization became longer for follow-up just to be safe.The relation between the hospitalization and the event was not provided.This is the report regarding the failure of releasing the loop.

• Brand Name: LIGATING DEVICE
• Type of Device: LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9448730
• MDR Text Key: 209461866
• Report Number: 8010047-2019-04230
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HX-20Q-1
• Device Lot Number: K7913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1