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

Model Number 59001

Device Problems Break (1069); Shipping Damage or Problem (1570)

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

Event Date 12/18/2014

Event Type  malfunction  

Event Description

A customer informed welch allyn of a vaginal speculum break in a patient.The doctor was using a medium speculum in a patient.When the speculum opened, the locking mechanism failed and the patient felt immediate pain.The doctor noticed that the bill of the speculum cracked down the middle and caused a 2 cm laceration down the right side of the patient's vaginal wall.The patient was already being treated with an antibiotic for an unrelated issue, so doctor extended the prescription by 5 days as a precaution.The patient came back in one week for a follow-up and the laceration was healing with no signs or symptoms of infection.No further treatment was provided to the patient.In subsequent follow-up, the customer identified that it was the lower bill of the speculum that broke.

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 previously discarded.The customer did return a damaged device to welch allyn, discovered before use, with the same break pattern as the device involved in the event.The device was reviewed by welch allyn engineering and 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.

• Brand Name: KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA
• Type of Device: VAGINAL SPECULA
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer Contact: pearley bhambri, ra director ; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4428357
• MDR Text Key: 5169030
• Report Number: 1316463-2015-00001
• 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
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59001
• Device Catalogue Number: 59001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• 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): Required Intervention