MAUDE Adverse Event Report: WELCH ALLYN 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 09/03/2014

Event Type  malfunction  

Event Description

The customer stated that the vaginal specula broke while being used on a patient during a gyn exam and lacerated the patient's vagina.Per the health care provider, the laceration was small, less than 1cm in length within the vagina.Bleeding was stopped with pressure - no suture needed.The patient was scheduled again in 3 days to follow-up and laceration was healing.The customer did not provide any patient information.

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 welch allyn.The speculum was examined by 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.Conclusion: evaluation conclusion (refer to the narrative above).

• 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 Contact: pearley bhambri, ra director ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4189194
• MDR Text Key: 18065934
• Report Number: 1316463-2014-00006
• Device Sequence Number: 1
• Product Code: HIB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2014
• 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
• Patient Outcome(s): Required Intervention