MAUDE Adverse Event Report: WELCH ALLYN, INC. KLEENSPEC 590 PREMIUM VAG SPEC LG CASE; SPECULUM, VAGINAL, NONMETAL

Model Number	59004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hillrom is reporting this event in an abundance of caution.The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.The vaginal speculum can be used with or without the illuminator.The actual vaginal speculum was not returned to hillrom.This device is a manually inserted, disposable vaginal speculum.It is unknown what caused the breakage at the bill of the device as the device could not be inspected.The customer has requested a replacement.Hillrom will continue to monitor any similar reported events.Based on this information, no further action is required and no further investigation will be performed.
Event or Problem Description
The customer reported while performing a pap test on a patient, vaginal speculum disposable premium 590 series large broke off inside of our patients vaginal cavity.The customer additionally clarified that during the exam, the bill of the spec broke off in the patient.The patient did not sustain any injury.The patient passed the broken piece overnight.The patient was prescribed a prophylactic antibiotic but reported it was not needed or taken as the customer reported that she passed the piece was passed and that she was fine.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: KLEENSPEC 590 PREMIUM VAG SPEC LG CASE
• Common Device Name: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13022188
• Report Number: 1316463-2021-00092
• Device Sequence Number: 4650720
• Product Code: HIB
• UDI-Device Identifier: 00732094143652
• UDI-Public: 732094143652
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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
• Device Model Number: 59004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female