MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-231D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem 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 myocardial infraction associated with fb-231d of thin bronchoscope group.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9517484
• Report Number: 8010047-2019-04636
• Device Sequence Number: 16266444
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FB-231D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other