MAUDE Adverse Event Report: WELCH ALLYN KLEENSPEC590 SERIES DISP. VAGINAL SPECULA

Model Number 59001

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

Patient Problems Abrasion (1689); Vaginal Mucosa Damage (2124)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Clinician inserted a vaginal speculum into patient and noticed it was not opening normally.The speculum broke in patient with no sound of breaking plastic.The clinician noticed a broken piece of speculum upon removal from which the patient received a 1cm abrasion.F/u with the clinician indicated the patient is fine with no treatment necessary.

Manufacturer Narrative

Welch allyn is reporting this is an abundance of caution.The returned vaginal speculum was evaluated by welch allyn engineering.The failure mode matched one that has been previously investigated and was determined to be related to damage sustained from shipping and handling.No further investigation will be performed.Evaluation conclusion(refer to the narrative above).

• Brand Name: KLEENSPEC590 SERIES DISP. VAGINAL SPECULA
• Type of Device: VAGINAL SPECULA
• Manufacturer (Section D): WELCH ALLYN; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer Contact: pearley bhambri,ra dir. ; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153-22 ; 3156852568
• MDR Report Key: 4358080
• MDR Text Key: 5179350
• Report Number: 1316463-2014-00014
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59001
• Device Catalogue Number: 59001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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