MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number KD-VC611Q-07201S

Device Problem Unclear Information (4052)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Insufficient information was provided by the user facility. Multiple follow ups were made to obtain additional information from the user facility via telephone and in writing but no information has been obtained. The reported device will not be returned as the user facility discarded the device following the procedure. The exact cause of the reported event cannot be confirmed. If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a therapeutic procedure, the device reportedly had an unspecified failure and caused patient injury.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8234406
• Report Number: 2951238-2019-00350
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170399381
• UDI-Public: 04953170399381
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: KD-VC611Q-07201S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/20/2018
• 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 Outcome(s): Other