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

Model Number	M00515031
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.However, the complainant reported that the device was not expired.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 hot biopsy forceps was used in a biopsy procedure performed on (b)(6) 2018.According to the complainant, during the end of the procedure, when attempting to remove one more polyp, the anesthesiologist felt an electrical shock and a hair singed offed one finger.The anesthesiologist wasn¿t wearing gloves when the shock occurred.Furthermore, he wasn't touching the patient but was touching the stretcher.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Visual analysis of the returned device found the cautery plug in good condition.Evidence of electrical conductivity was noted in the distal section.Functional inspection found the device passed the electrical test.According to the available information, the active cord used in this procedure was olympus mh969 and the monopolar generator was valleylab.The dfu indicates that the active cord used in this procedure must be olympus brand generator, this omission could contribute to the reported failure and cause the failure found on the device.The dfu instructions must be followed to ensure the correct use of the device.Therefore, use/user error is the most probable cause for this complaint since there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.A labeling review was performed and found the dfu instructions were not followed since as per available information, the active cord used was olympus mh969 (m00561250) and the monopolar generator used was valleylab.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 hot biopsy forceps was used in a biopsy procedure performed on (b)(6) 2018.According to the complainant, during the end of the procedure, when attempting to remove one more polyp, the anesthesiologist felt an electrical shock and a hair singed offed one finger.The anesthesiologist wasn¿t wearing gloves when the shock occurred.Furthermore, he wasn't touching the patient but was touching the stretcher.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: RADIAL JAW¿ 4
• Common Device Name: FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7521170
• Report Number: 3005099803-2018-01583
• Device Sequence Number: 11119069
• Product Code: KGE
• UDI-Device Identifier: 08714729790136
• UDI-Public: 08714729790136
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101657
• 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): 04/19/2018

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: M00515031
• Device Catalogue Number: 1503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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: Other