MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MAJ-2027-E EC-S10 SET; ENDOCAPSULE SMALL INTESTINAL CAPSULE

Model Number MAJ-2027

Device Problems No Display/Image (1183); Sticking (1597)

Patient Problems Discomfort (2330); Obstruction/Occlusion (2422)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event is due to the patient¿s pre-existing condition of small bowel blockage.The instruction manual provides contraindications and warnings which states, patients with known or suspected intestinal strictures, adhesions, diverticulum, obstruction, or fistulas that may block the passage of the capsule endoscope.Patients with these physical features risk retention of the capsule endoscope.Prior to using the capsule endoscope, the physician should consider performing a contrasted x-ray series in patients with the conditions mentioned.

Event Description

Olympus was informed that during a small bowel inspection procedure, two endoscope capsules became stuck inside of the patient due to a known blockage in the patient¿s small bowel.Both endoscope capsules were retrieved from the patient by surgery.The user facility reported when the first endoscope capsule was activated, it showed an image as expected.Shortly after ingesting the endoscope capsule, the recorder stopped blinking and the image went black.The physician gave the patient a second endoscope capsule and the same issue occurred.The user facility reported that they did not troubleshoot the endoscope capsules or the recorder prior to use.The patient was then taken for x-ray and ct scan which confirmed the patient¿s small bowel blockage causing both endoscope capsules to become stuck.The user facility advised the patient to go home and wait for the endoscope capsules to pass naturally.Due to the discomfort experienced by the patient from the small bowel blockage, the patient was admitted for surgery two days later.The surgery was successful and the endocapsules were removed from the patient.The patient has been discharged and is doing fine.One (1) of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).Based on the oem¿s investigation, the root cause of the reported event could not be conclusively determined, however, the most probable cause of the reported event could be attributed to the device not being attached on the correct position, the patient became too close to a radio device which could have compromised the radio waves, the position of the antenna sheet may have moved from exercise or movement from the patient.A dhr review could not be conducted due to no lot number provided.The instruction manual provides instruction to mitigate complications during use which states, please check whether the antenna sheet is attached on correct position, do not let a patient take several capsules at the same time and to check whether the capsule might be stuck in the patient's body before introducing another capsule.No device was returned for evaluation.Also a dhr review could not be conducted due to no lot number provided.

• Brand Name: MAJ-2027-E EC-S10 SET
• Type of Device: ENDOCAPSULE SMALL INTESTINAL CAPSULE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7264358
• MDR Text Key: 99847157
• Report Number: 2951238-2018-00097
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• PMA/PMN Number: PK123421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MAJ-2027
• Device Catalogue Number: MAJ-2027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOCAPSULE RECORDER: RE-10, SN (B)(4); OLYMPUS ENDOCAPSULE RECORDER: RE-10, SN (B)(4)
• Patient Outcome(s): Other