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

Model Number	59001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Welch allyn/hillrom is reporting this event in an abundance of caution.The actual vaginal speculum was not returned to welch allyn.This device is a manually inserted, disposable vaginal speculum.The root cause of these very rare failures was determined to likely be related to potential impacts or loads on the shipping containers during transit or storage.Based on this information, no further action is required and no further investigation will be performed.
Event or Problem Description
Hillrom received a report from a the account that the vaginal speculum broke inside of a patient during a routine exam.There was no serious patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: KLEENSPEC 590 PREMIUM VAG SPEC MD CASE
• Common Device Name: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 12196105
• Report Number: 1316463-2021-00026
• Device Sequence Number: 14468717
• Product Code: HIB
• UDI-Device Identifier: 00732094143676
• UDI-Public: 732094143676
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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
• Operator of Device: No Information
• Device Model Number: 59001
• 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: 06/30/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1