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

Model Number 59000

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

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

Event Date 01/09/2015

Event Type  malfunction  

Event Description

Welch allyn received an email from a distributor that a doctor was performing a gyn procedure and the vaginal speculum broke in the patient's vagina.The break caused a superficial laceration in the patient's vagina.The patient did not require any medical treatment and is fine.

Manufacturer Narrative

Welch allyn is reporting this in an abundance of caution.The actual speculum involved in the incident was returned and evaluated by welch allyn.The speculum was evaluated by engineering, and the failure mode matches the one that was 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: 4477877
• MDR Text Key: 18088263
• Report Number: 1316463-2015-00002
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59000
• Device Catalogue Number: 59000
• Device Lot Number: 218524
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• 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
• Patient Outcome(s): Required Intervention