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

Model Number M00513330

Device Problems Component Missing (2306); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

While doing a colonoscopy, md asked for biopsy forceps.Md stated it felt rough going down the scope channel.When the forceps got to the end of the scope there was a metal wire that was partially pushed out of the scope.Forceps were withdrawn and wire came back in the scope channel.Scope was withdrawn from patient and new scope used to complete colonoscopy.Upon examination of forceps, the center needle and one of the operating wires were missing.Manufacturer response for radial jaw 4, radial jaw 4 (per site reporter).They are in the process of retrieving the device.

• Brand Name: RADIAL JAW 4
• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16270900
• MDR Text Key: 308452672
• Report Number: 16270900
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00513330
• Device Lot Number: 30594383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Male
• Patient Weight: 99 KG