MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.Based on the reported event, it is presumed that the reported complications were not due to the malfunction of the device, but occurred as a general complications of the procedure.

Event Description

On december 5, 2019, olympus medical systems corp.(omsc) received a literature titled ¿use of an ultrathin vs thin bronchoscope for peripheral pulmonary lesions¿.The literature reported the result of 356 cases (ultrathin bronchoscope group: 177cases.The ratio of male-to-female ratio was 107:70.The median age of the patients was 71 years.Thin bronchoscope group: 179cases.The ratio of male-to-female ratio was 111:68.The median age of the patients was 72 years.) of the multiple sampling methods for the diagnosis of peripheral pulmonary lesions from february 2013 to august 2016.The literature indicated that ultrathin bronchoscope (y-0025 or y-0058), ultrasonic probe um-s20-17s, and/or disposable biopsy forceps (fb-32d or fb-233d in single use guide sheath kit k-201) might be used for ultrathin bronchoscope group.The literature also indicated that thin bronchoscope (evis lucera bronchofibervideoscope olympus bf type p260f ; bf-p260f), single use guide sheath sg-200c in single use guide sheath kit k-201, disposable biopsy forceps fb-231d, guiding device cc-6dr-1, and/or single use aspiration needle na-401d-1521 might be used for thin bronchoscope group.In the subject cases with ultrathin bronchoscope, 2 cases of pneumothorax, 2 cases of pneumonia, and 1 case of bleeding reportedly occurred.In the subject cases with thin bronchoscope, 2 cases of pneumothorax, 2 case of bleeding, 1 case of pneumonia, 1 case of vomiting, 1 case of nausea, and 1 case of myocardial infraction reportedly occurred.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.This is a report on bleeding associated with um-s20-17s 1 of 1 report with ultrathin bronchoscope.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• 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: 9517362
• MDR Text Key: 189145471
• Report Number: 8010047-2019-04606
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other