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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a polypectomy of a large pedunculated polyp in the sigmoid, the subject device was used.The loop was closed and could not be detached as the wires were bent in the handle.The user cut wires and loosened the loop with help of diathermy.The intended procedure was completed with large clips.The sedation and duration of the examination was extended from 30 minutes to 110 minutes.The patient had massively prolonged intravenous anaesthesia with drop in blood pressure and circulatory problems.It was reported circulatory support was needed.There was thermal damage to the intestinal wall due to needle knife with diathermy.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.It was additionally reported that antibiotic therapy for shielding the thermal damage on the intestinal wall due to the high-frequency device was also performed.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.According to the provided photos, omsc confirmed that the operating pipe was deformed and the closed loop was not detached from the hook.Eight unopened devices were returned.General appearance of all the returned devices were confirmed.No abnormalities that could lead to the reported event could not be confirmed.Movement of devices was confirmed by protruding the loop from the tube sheath, performing ligation and releasing the loop.The devices were functioning without any problems.The reported event such as ¿the loop cannot be detached, or deformation of the operation wire¿ could not be replicated.The manufacturing record was reviewed and found no irregularities.Based on the investigation for the provided photos, omsc presumes that the event occurred due to the following occurrence mechanism.*the proximate side of the loop was retracted into the coil sheath.This caused the loop to get stuck between the coil sheath and the hook.As a result, the slider could not move and the loop could not detach from the coil sheath.The slider was forcibly moved in the state as above.This caused the operating wire and the operating pipe to break.The above phenomenon occurs by the following mechanism.The loop was detached from the hook while the coil sheath was being retracted into the tube sheath, or the loop was hung on to the tissue and it was positionally fixed at the distal end of the tube.As a result, the loop was unable to release.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.The pulling of the tube sheath caused the loop to move with the distal end of the tube sheath toward the coil sheath.Subsequently, the loop entered the coil sheath and got caught between the hook and the coil sheath.The above device handling has warned in the instruction manual as follows.*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.In addition, it is presumed that the circulatory support was needed since the procedure was extended for emergency treatment and the patient had to be re-sedated repeatedly, which caused drop in blood pressure and circulatory problems.Thermal damage to the intestinal wall likely occurred because the needle knife was touched to it as the loop had to be separated from the polyp stem with a needle knife in emergency treatment.

• 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: 10964019
• MDR Text Key: 220242347
• Report Number: 8010047-2020-09991
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HX-400U-30
• Device Lot Number: 02V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention