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

Model Number	M00513412
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 in the esophagus during an esophagogastroduodenoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a foreign body was found inside the cup when they opened the biopsy forceps.The foreign body dropped into the patient and they were unable to find it.They used another of the same forceps to complete the case.Additionally, it was reported that the foreign body was light yellow orange that looked like the catheter of the forceps.There were no serious injury nor adverse patient effects reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in the esophagus during an esophagogastroduodenoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a foreign body was found inside the cup when they opened the biopsy forceps.The foreign body dropped into the patient and they were unable to find it.They used another of the same forceps to complete the case.Additionally, it was reported that the foreign body was light yellow orange that looked like the catheter of the forceps.There were no serious injury nor adverse patient effects reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).Visual inspection found the device does not have any visible failure or residues that indicates that a foreign matter was present.Based on the available information, the issue occurred during the procedure.As the device was withdrawn from the pouch and used, it is difficult to determine where the reported foreign matter was acquired.Therefore, the conclusion code selected for this complaint is cause not established.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.

• 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: 7992703
• Report Number: 3005099803-2018-60976
• Device Sequence Number: 1255805
• Product Code: FCL
• UDI-Device Identifier: 08714729778004
• UDI-Public: 08714729778004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/05/2018

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 Expiration Date: 07/13/2021
• Device Model Number: M00513412
• Device Catalogue Number: 51309
• Device Lot Number: 0022375917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1