MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BALLOON DILATOR V (WITH KNIFE)

Model Number BD-VC431Q-1240-20

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

Patient Problem Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

The subject device had been discarded at the facility, and it did not return for investigation. Therefore, the phenomenon of the reported event could not be confirmed. The manufacturing record was reviewed and found no irregularities. Since the subject device could not be confirmed and dhr presented no abnormalities, the exact cause of the reported event could not be determined. Therefore, it was not identified whether pancreatitis was caused by the actual product or not. Based on the past cases, it is possible that the balloon was ruptured. It can be inferred that the forceps elevator was raised excessively, or the device was moved back and forth when the balloon was not completely deflated. The balloon was possibly rubbed from the effect of contacting a metal area of the endoscope, causing deflation of the balloon. The above device handling about deflation of the balloon has been warned in the instruction manual. A supplemental report will be submitted if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp. (omsc) received the following report from the user. During a duodenal papilla incision, the subject device was used. After the user incised the duodenal papilla with the cutting wire of the subject device, the balloon of the subject device could not inflate. The intended procedure was completed with the competitor's device. At a later date, the user confirmed that the patient had been diagnosed with pancreatitis. The causal relationship with our products is unknown. No further information was provided. Omsc will submit one medical device reports (mdr) of the subject device for postoperative pancreatitis.

• Brand Name: SINGLE USE BALLOON DILATOR V (WITH KNIFE)
• Type of Device: BALLOON DILATOR
• 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: 11830725
• MDR Text Key: 250796977
• Report Number: 8010047-2021-06391
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: BD-VC431Q-1240-20
• Device Lot Number: 03K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/19/2021
• 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 Treatment Data

Date Received: 05/17/2021 Patient Sequence Number: 1