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 09/29/2014

Event Type  malfunction  

Event Description

Welch allyn distributor informed welch allyn of a customer who had a vaginal speculum break in the patient and claims injury.On (b)(6) 2014 the emergency room physician performed a routine pap smear test on (b)(6) patient.Upon opening the speculum, the bill broke in half.The physician removed the broken piece and noted a tear in the vaginal tissue with some bleeding.No treatment was required at that time for the tear.The patient was instructed to follow up with her gynecologist.The emergency room physician called the patient on (b)(6) 2014 and was told by the patient that she returned to a different emergency department for treatment of a uti and vaginitis and upon exam was informed that the tear was healing.No treatment for tear was necessary by secondary hospital, as well.

Manufacturer Narrative

Welch allyn is reporting this in abundance of caution.The customer did not return the device to welch allyn, but completed a questionnaire with a drawing of a vaginal speculum device indicating the break location and manner in which the vaginal speculum broke.The questionnaire and marked-up picture was reviewed by welch allyn engineering and the failure mode matches 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, director ; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4268456
• MDR Text Key: 21847029
• Report Number: 1316463-2014-00010
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• 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
• Device Lot Number: 228071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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