MAUDE Adverse Event Report: WELCH ALLYN, INC. KLEENSPEC 590 PREMIUM VAG SPEC SM CASE; SPECULUM, VAGINAL, NONMETAL

Model Number 59000

Device Problem Fracture (1260)

Patient Problem Laceration(s) (1946)

Event Date 12/15/2022

Event Type  malfunction  

Event Description

It was reported that during an annual gyn exam and pap, with use of a kleenspec (size small), the ¿lower bill of speculum broke, split lengthwise¿ during use.The customer states a ¿small amount of vaginal bleeding¿ occurred, however there was no allegation of medical intervention or delay from the event.This event was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

During follow up with the customer, it was noted, ¿the nurse who was using the specula was able to remove it and use another specula of the same size without incident.¿ the patient is a 59-year-old female weighing 230 pounds.As a precaution, all materials from this lot were taken out of use in the practice and replaced with another lot.The welch allyn kleenspec 790 series cordless illumination system can be used with or without the kleenspec 590 series disposable vaginal speculum.When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation, and curettage (d&c) biopsy, and electrosurgery.The cordless illuminator can be used independent of the speculum as a general-purpose light source.In this event a ¿small amount of vaginal bleeding¿ occurred, however there was no allegation of patient injury, medical intervention, or delay from the event; however, if the malfunction were to recur, and the speculum breaks while in use (possibly a result of a mold flaw, shipping damage, or other stresses put on the speculum) it is likely to cause or contribute to a serious injury or death.Therefore, hillrom considers this complaint reportable.At this time there has been no return of the affected product.If there is any additional information, or if the lot is returned, a supplemental report will be submitted.Device not returned to manufacturer.

• Brand Name: KLEENSPEC 590 PREMIUM VAG SPEC SM CASE
• Type of Device: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street east; skaneateles falls NY 13153
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16120970
• MDR Text Key: 307042551
• Report Number: 1316463-2023-00003
• Device Sequence Number: 1
• Product Code: HIB
• UDI-Device Identifier: 00732094143690
• UDI-Public: 732094143690
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 59000
• Device Lot Number: 2022251
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1