MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4 SINGLE-USE BIOPSY FORCEPS; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number M0051330

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Provider was collecting colon biopsies and the biopsy forcep got stuck in the channel and unable to be removed from the channel.Switched to an egd scope and used standard forceps instead.

• Brand Name: RADIAL JAW 4 SINGLE-USE BIOPSY FORCEPS
• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15216568
• MDR Text Key: 297791790
• Report Number: 15216568
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0051330
• Device Lot Number: 28964089
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2022
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/12/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1