MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 800 CONNECTOR ASSEMBLY TOOL; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400271
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for an artificial urinary sphincter(aus) implant surgery, the physician received a connector assembly tool with no red label indicating that the instrument had been sterilized.The customer thought that there was no information on the package of the connector tool stating that this instrument was not sterile, but there was information on the packaging that indicated that the connector assemble tool was not sterilized.Because of that, the physician did not sterilize the connector assembly tool and the surgery had to be postponed.It was noted that the packaging had not been damaged.There were no patient complications related to this event.

• Brand Name: 800 CONNECTOR ASSEMBLY TOOL
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10816496
• Report Number: 2183959-2020-05381
• Device Sequence Number: 19878215
• Product Code: EZY
• UDI-Device Identifier: 00878953000831
• UDI-Public: 00878953000831
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P010020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: Lay User/Patient
• Device Model Number: 72400271
• Device Catalogue Number: 72400271
• Device Lot Number: 1000417582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention