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

Model Number	M00513402
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Problem code 1888 captures the reportable event of hemorrhage.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in a procedure on an unknown date.According to the complainant, the forceps cut too deeply.Post procedure, the patient experienced a gi bleed and was sent to the hospital.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.

• 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: 8231544
• Report Number: 3005099803-2019-00029
• Device Sequence Number: 1746386
• Product Code: FCL
• UDI-Device Identifier: 08714729778028
• UDI-Public: 08714729778028
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00513402
• Device Catalogue Number: 51475
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization