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

Model Number HX-400U-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fever (1858)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation and investigation.Since the lot number of the subject device was unknown, the dhr for over the past year prior to the date of occurrence (b)(6) 2021 was inspected.No abnormalities detected in the dhr of the following items which relate to the reported phenomenon.Nonconforming product report due to the following reasons, it was decided that it was not necessary to perform an investigation by using a device with the same structure or a similar device.The product comment provided in the etq indicates that the patient had a fever next day by applying an electrical current to the body tissue when removing the tumor.(causal relationship is unknown).Therefore, patient's fever is not related to the subject device.¿the loop could not be detached from the hook¿ is a known phenomenon, and it is possible to infer its cause from the description of the similar investigation results in the past.No abnormalities detected in the dhr investigation result.Conclusion summary¿ fever: the product comment provided in the etq indicates that the patient had a fever next day by applying an electrical current to the body tissue when removing the tumor.(causal relationship is unknown) therefore, patient's fever is not related to the subject device.Detachment fault of loop from the hook: the exact cause of the problem could not be conclusively identified, since the device was not retuned for the investigation.No abnormalities were detected in the device history record.Therefore, the reported phenomenon which was pointed out could not be confirmed.Based on past cases, it is possible that the loop could not detach from the hook due to the following mechanisms.When the loop was detached from the hook, it was either the coil sheath was retracted into the tube sheath, or the distal end of the tube sheath was pressed against the tissue with the loop being snared to the tissue.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.When the tube sheath was pulled to the proximal side, the loop pulled the tube, and it was retracted into the coil sheath.As a result, the loop became intermeshed in between the hook and inside the coil and stopped moving.Content of the instruction manual was confirmed (drawing number: (b)(4), revision number: 04).The instruction manual contains the following descriptions to describe about detachment fault of loop from the hook.However, there are no descriptions regarding fever.Do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.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.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.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.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Never use excessive force to operate the instrument.This could damage the instrument.

Event Description

Olympus medical systems corp.(omsc) was informed by the physician that the sheath of the subject device could not be retracted and the subject device could not be put off a polyp after the surgeon ligated the polyp during a polypectomy on sigmoid colon.The surgeon detached the handle of the subject device and removed the endoscope.The surgeon re-inserted the endoscope and tried to retract the sheath of subject device using a forceps but could not do it.The surgeon used a surgical electronic snare (sd-210u-25) and could cut the polyp at two points (at the upper of and the bottom of snare), because the polyp was large.However, during cutting the polyp at the upper of snare, the mucous membrane in the vicinity was electrically damaged, and fever was observed the next day.The patient was hospitalized four days longer than planned.The surgeon did not use a loop cutter to retract the sheath during the procedure.Omsc will submit a report of hx-400u-30, and another of sd-210u-25.This is the report for hx-400u-30.

Manufacturer Narrative

This supplemental report is being submitted to withdraw mfr report #8010047 - 2021 - 11464.On (b)(6), the initiator informed as bellow.The doctor did not estimated that there was a relationship between energizing the mucous membrane in the vicinity and fever.As a result of a fever, the doctor decided that the patient was needed the hospitalization.Olympus medical systems corp.(omsc) confirmed that there was no mdr reportable malfunction or adverse event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12444132
• MDR Text Key: 273330367
• Report Number: 8010047-2021-11464
• 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 Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization