Welch Allyn, Inc. 901071 (REF 403620)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00732094147773), received between Jun 29, 2017 and Dec 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Break; Break

  THE CUSTOMER REPORTED WHILE PERFORMING A PAP TEST ON A PATIENT, VAGINAL SPECULUM DISPOSABLE PREMIUM 590 SERIES LARGE BROKE OFF INSIDE OF OUR PATIENTS VAGINAL CAVITY. THE CUSTOMER ADDITIONALLY CLARIFIED THAT DURING THE EXAM, THE BILL OF THE SPEC BROKE OFF IN THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY. THE PATIENT PASSED THE BROKEN PIECE OVERNIGHT. THE PATIENT WAS PRESCRIBED A PROPHYLACTIC ANTIBIOTIC BUT REPORTED IT WAS NOT NEEDED OR TAKEN AS THE CUSTOMER REPORTED THAT SHE PASSED THE PIECE WAS PASSED AND THAT SHE WAS FINE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022188 ↗
• MalfunctionJun 29, 2017Fracture; Fracture

  A WELCH ALLYN SALES REPRESENTATIVE IN THE (B)(4) INFORMED WELCH ALLYN CUSTOMER CARE THAT A SECOND 59004 KLEENSPEC LARGE DISPOSABLE VAGINAL SPECULUM BROKE INSIDE A PATIENT DURING AN EXAMINATION. THIS SECOND VAGINAL SPECULUM BROKE THE DAY AFTER THE FIRST REPORTED BREAK AND IS FROM THE SAME CUSTOMER, LOT, AND BOX AS REPORTED ON MDR 1316463-2017-00007. BOTH BRAKES OCCURRED APPROXIMATELY 2 WEEKS PRIOR TO WELCH ALLYN AWARENESS. WELCH ALLYN SALES REPRESENTATIVE IDENTIFIED THE ISSUE AS A LOWER BILL BREAK. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT'S VAGINA WITHOUT INCIDENT AND THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6678006 ↗
• MalfunctionJun 29, 2017Fracture; Fracture

  A WELCH ALLYN SALES REPRESENTATIVE IN THE (B)(6) INFORMED WELCH ALLYN CUSTOMER CARE THAT A 59004 KLEENSPEC LARGE DISPOSABLE VAGINAL SPECULUM BROKE INSIDE A PATIENT DURING AN EXAMINATION. A PHOTO OF THE BROKEN VAGINAL SPECULUM INVOLVED IN THE EVENT INDICATED THAT APPROXIMATELY 0.5 INCH OF THE LEADING EDGE OF THE LOWER BILL BROKE OFF FROM THE VAGINAL SPECULUM. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT'S VAGINA WITHOUT INCIDENT AND THE PATIENT WAS NOT INJURED IN THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6677072 ↗