MAUDE Adverse Event Report: WELCH ALLYN KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

Model Number 59001

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Vaginal Mucosa Damage (2124)

Event Date 08/02/2015

Event Type  malfunction  

Manufacturer Narrative

Welch allyn is reporting this in an abundance of caution.The customer did not return the device that broke in use to welch allyn as the device was discarded.The customer did take a photograph of the actual device that broke in use.The photograph was reviewed by welch allyn engineering and assessment of the photograph determined the failure mode matched one that has been previously investigated.The root cause of these very rare failures was determined to be related to potential impacts or loads on the shipping containers during transit or storage.No further investigation will be performed.(b)(4).Not returned to manufacturer.

Event Description

A customer informed welch allyn of a vaginal speculum break in a patient during a pelvic exam.When the speculum was opened the lower part of the speculum broke into two pieces lengthwise.The larger part of the speculum was removed but the smaller piece of the speculum with a sharp edge was stuck on a piece of vaginal skin just distal to the vaginal opening.This was the patient right lower vaginal area, around the 7 o'clock position.Based on information from the clinician, the patient appeared to be in pain and clinched her vaginal muscles.The speculum was pushed into the vagina in attempts to get the sharp edge off of the piece of vaginal skin.A sharp piece of the speculum cut the patient's skin.The laceration was small and superficial.Patient did have bleeding but it was well controlled when pressure was applied using a scopette.Upon removal of speculum, the patient did not report any further pain.The speculum was recovered and put into a plastic bag but was accidently disposed of by the hospital.No lot or cavity number could be provided.The customer did not provide any patient information.

• Brand Name: KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA
• Type of Device: VAGINAL SPECULA
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer (Section G): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: pearley bhambri ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 5020867
• MDR Text Key: 23944895
• Report Number: 1316463-2015-00034
• Device Sequence Number: 1
• Product Code: HIB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 59001
• Device Catalogue Number: 59001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention