MAUDE Adverse Event Report: BOSTON SCIENTIFIC BIOPSY CAP

Catalog Number M00545260

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

Pt was undergoing ercp and it was noted that a sponge was in the biopsy channel from a previous procedure.It is believed that the sponge material matches that of the biopsy cap.Scope was removed and new scope was utilized.Pt required no further treatment.

• Brand Name: BIOPSY CAP
• Type of Device: BIOPSY CAP
• Manufacturer (Section D): BOSTON SCIENTIFIC; warlborough MA 01752
• MDR Report Key: 7057368
• MDR Text Key: 92977518
• Report Number: MW5073534
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Catalogue Number: M00545260
• Device Lot Number: 20571700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 95