MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)

Model Number KD-VC611Q-07203S

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, during a therapeutic endoscopic retrograde cholangiopancreatography after removal of the biliary prosthesis, the physician used the sphincterotome to enter the papilla of the bile ducts not visible through a diverticulum in order to visualize stenosis or stones.When the subject device was removed from the scope, the nurse noticed that the piece of metal used to bandage it was cut in half and one of the two parts were missing.The piece was searched in the working channel and inside the patient with the endoscope camera, but it was not found.The piece may have remained in the duodenum but reportedly, it was so small and thin, there was little risk for the patient.It was also not visible by radiograph.The procedure was prolonged by 30 minutes.There were no reports of further patient harm.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19051716
• MDR Text Key: 339494586
• Report Number: 9614641-2024-00856
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170399428
• UDI-Public: 04953170399428
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-VC611Q-07203S
• Device Lot Number: 29V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/05/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR