MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number	SBC-580
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient's age was around 40 years.No event date was given, therefore an approximate date of (b)(6) 2018 was used as the event date.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the lid of the seal biopsy valve came open when removing a device causing fluid to leak and got on to a caregiver's face.An irrigation to the caregiver's eyes was done for 15 minutes.There was no known impact or consequence to the patient as a result of this event.The caregiver was reported to be fine.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7881413
• Report Number: 3005099803-2018-60477
• Device Sequence Number: 1939628
• Product Code: OCX
• UDI-Device Identifier: 00840253110060
• UDI-Public: 00840253110060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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 Model Number: SBC-580
• Device Catalogue Number: 2095-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59