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

Model Number	M00513330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During intra-op endoscopy, surgeon placed radial jaw biopsy forcep into lumen of gastroscope to obtain a specimen.Surgeon was successful in obtaining biopsy, but the biopsy forcep ended getting stuck inside of the gastroscope.Scope will be sent to olympus for evaluation.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9474125
• Report Number: 9474125
• Device Sequence Number: 19495206
• Product Code: FCL
• UDI-Device Identifier: 08714729745549
• UDI-Public: (01)08714729745549
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/25/2019
• Report Date (Section F): 11/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: M00513330
• Device Lot Number: 24314568
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 11/25/2019