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

Model Number 59001

Device Problem Fracture (1260)

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide a lot number therefore welch allyn was unable to review the device history record for the speculum.As the device and packaging was disposed of by the user we were unable to determine if this was a single rail or double rail speculum.Fourteen representative samples were returned to welch allyn for evaluation.The specula were a mix of single rail and double rail specula.Upon visual inspection of all 14 returned specula no damage was observed.Microscopic examination of the single rail specula showed no damage or cracking.The single rail specula were last manufactured on 30 july 2014.The enhanced double wall specula design was introduced in august 2014.Based on this information, no further action is required.

Event Description

Welch allyn received a report stating, kleenspec 590 series disposable vaginal speculum broke while being used on a patient during a pelvic exam.The speculum was examined by the physician prior to use and no visible cracks were noted.The physician inserted the speculum into the patient's vagina and immediately upon opening of the speculum, the upper blade shattered.Approximately half of the left side of the upper blade broke off of the speculum.The broken pieces were removed from the patient's vagina.The patient sustained an approximate 1 to 2 cm vaginal wall laceration from the sharp edge of the broken blade.Pressure was applied and the bleeding subsided.The patient recovered without further treatment or incident.

• Brand Name: KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA
• Type of Device: VAGINAL SPECULA
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer Contact: edward o'neil ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3155544055
• MDR Report Key: 6562897
• MDR Text Key: 75101277
• Report Number: 1316463-2017-00004
• Device Sequence Number: 1
• Product Code: HIB
• UDI-Device Identifier: 00732094143676
• UDI-Public: 00732094143676
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other