MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RADIAL JAW¿ 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00515181
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	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis found that the device does not have any failure; however, an unknown piece of metal was found returned with the device, and it is not a part of the complaint device.A functional test determined that the returned device opens and closes within specification, without any issues.The unknown piece of metal was measured and the evaluation concluded that it was not part of the device.The returned device review included a visual, functional, and dimensional evaluation, which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, the most probable root cause cannot be confirmed.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw¿ 4 pulmonary biopsy forceps was used in the right lower lobe (b8) during a transbronchial lung biopsy (tblb) and bronchoalveolar lavage (bal) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, resistance was felt when the device was inserted through the scope, and a biopsy was performed.When the device was re-inserted into the scope for another biopsy, resistance was felt.The device was removed and it was found that the pullwire was damaged.The procedure was completed with another radial jaw¿ 4 pulmonary biopsy forceps.Additionally, after the procedure when the used scope was washed, the bronchoscope was found to be leaking.There were no patient complications reported a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿good¿.This event has been deemed a reportable event based on the investigation results; foreign matter.

• Brand Name: RADIAL JAW¿ 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7165425
• Report Number: 3005099803-2017-04008
• Device Sequence Number: 1497461
• Product Code: FCL
• UDI-Device Identifier: 08714729792864
• UDI-Public: 08714729792864
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/07/2017

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: 07/19/2020
• Device Model Number: M00515181
• Device Catalogue Number: 1518
• Device Lot Number: 0020914474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1