MAUDE Adverse Event Report: OBP CORPORATION ER-SPEC; SPECULUM, VAGINAL, NONMETAL

Model Number C020120-1

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2015

Event Type  malfunction  

Event Description

The dr.Was performing a vaginal exam and inserted the speculum without difficulty and attempted to open the speculum and it broke at the clear u shaped piece.Another exam was attempted with a new speculum and it broke in the same area.

• Brand Name: ER-SPEC
• Type of Device: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): OBP CORPORATION; 360 merrimack street; bldg. 9, floor mezzanine; lawrence, MA 01843
• MDR Report Key: 5090433
• MDR Text Key: 26264102
• Report Number: 5090433
• Device Sequence Number: 1
• Product Code: HIB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: C020120-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1