Scope Warmer Disposable Seal C3101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915116811), received between Mar 15, 2022 and Mar 31, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: [NAME] HOSPITAL. THIS IS A COMPLAINT FROM THE HOSPITAL; FOREIGN MATERIAL (HAIR?) WAS CONTAMINATED IN THE STERILIZED POUCH. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A HOSPITAL INVENTORY NEW C3101. THE INVESTIGATION REPORT HAS NOT BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. TYPE OF INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW C3103 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731786 ↗
• MalfunctionMar 15, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA - INCOMING INSPECTION. DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO # (B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: JANUARY 13, 2022. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. HAIRLIKE OBJECT IN POUCH - C3101 LOT # 1424968 (1 EA.). PATIENT STATUS: NA - NO PATIENT INVOLVEMENT. TYPE OF INTERVENTION: NA - INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776060 ↗