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	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's phone number is (b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr 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 during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the forceps took so much tissue that severe bleeding occurred after taking a biopsy in the esophagus.The procedure was completed at this time, and the patient stayed one day in the hospital for monitoring.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the forceps took so much tissue that severe bleeding occurred after taking a biopsy in the esophagus.The procedure was completed at this time, and the patient stayed one day in the hospital for monitoring.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's phone number is (b)(6).Block h6: patient code 1888 captures the reportable event of severe bleeding.Block h10: visual analysis found the returned device in good condition and no visual damage was found.Dimensional and functional inspection was performed and no anomalies were noted.The analysis of the returned device found no evidence of any defect that could have contributed to the reported event.Therefore, the most probable cause is "adverse event related to procedure", as the event occurred during the procedure and there is no evidence of any device defect that may have influenced the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A similar complaint review was performed and no other complaints have been reported for the specified lot.A labeling review was performed and found the device was used in accordance with the directions for use (dfu)/label.Additionally, hemorrhage is listed within the dfu as a potential adverse event associated with the use of the device.

• 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: 8848358
• Report Number: 3005099803-2019-03821
• Device Sequence Number: 2548920
• Product Code: FCL
• UDI-Device Identifier: 08714729778028
• UDI-Public: 08714729778028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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 Expiration Date: 04/21/2022
• Device Model Number: M00513402
• Device Catalogue Number: 51475
• Device Lot Number: 0023677708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR