MAUDE Adverse Event Report: COOPERSURGICAL, INC. SANI-SCOPE DISP ANOSCOPE

Model Number 82420

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2016

Event Type  malfunction  

Event Description

"a number of the disposable anoscopes have broken at the tip while in use (during removal from patient)." (b)(4).

• Brand Name: SANI-SCOPE DISP ANOSCOPE
• Type of Device: SANI-SCOPE DISP ANOSCOPE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5922648
• MDR Text Key: 230227271
• Report Number: 1216677-2016-00058
• Device Sequence Number: 1
• Product Code: HIB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K841909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 82420
• Device Catalogue Number: 82420
• Device Lot Number: NONE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other