Scope Warmer Bottle C3001Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607915116798), received between Aug 19, 2016 and Jun 21, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Noise, Audible; Noise, Audible

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [HOSPITAL]. THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP VIA EMAIL; DESPITE THE BOTTLE BEING EMPTY, IT SOUNDED LIKE IT WAS FILLED WITH WATER. THIS UNIT WILL BE RETURNED. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590353 ↗
• MalfunctionOct 23, 2023Material Integrity Problem; Material Integrity Problem

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: "I SHARE WITH YOU THAT WE RECEIVED A COMPLAINT FROM THE CUSTOMER REGARDING THE THERMOS AND BASE PURCHASED IN [INVOICE]. THE CLIENT INDICATES THAT AT THE TIME OF WASHING THE BASE CAME OFF. C3001 LOT 1457755, C3002 LOT 1456567" ADDITIONAL INFORMATION WAS RECEIVED ON 10-OCT-23 BY EMAIL FROM [CUSTOMER] "THE INCIDENT OCCURRED LAS (B)(6) 2023 , THE HOSPITIAL STILL NO CONFIRM IF THE MODEL C3002 ALSO IS INVOLVED IN THE COMPLAINT, THE SCOPE WARMER WAS ALREADY USED, THE INCIDENT WAS AFTER THE PROCEDURE WHILE THE TECHNICIAN WAS CLEANING THE PRODUCT. THE PRODUCT WILL BE RETURNED." TYPE OF INTERVENTION: NI. PATIENT STATUS: GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992143 ↗
• MalfunctionDec 13, 2022Material Integrity Problem; Material Integrity Problem

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: TRANSLATION (VIA DEEPL): DEFECT, NO FUNCTION. ORIGINAL: DEFEKT, KEINE FUNKTION. TODAY WE RECEIVED A CALL AND LATER AN EMAIL FROM [NAME] REGARDING A DEFECT C3001 (LOT: 1320566) AND C3002 (LOT: 1238952) FROM 1010019 [NAME]. [NAME] WAS ASKED TO REPAIR THESE 2 PRODUCTS BUT THEY ARE FINE TO RECEIVE REPLACEMENTS INSTEAD. INTERVENTION: BEFORE USE: NA. PATIENT STATUS: BEFORE USE: NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974166 ↗
• MalfunctionOct 12, 2022Material Integrity Problem; Material Integrity Problem

  PROCEDURE PERFORMED: NA (BEFORE USE). EVENT DESCRIPTION: [FACILITY] THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). REPORT FROM THE SALES REP: WHEN POURING HOT WATER INTO C3001 AND HOLDING THE CANISTER IN PREPARATION FOR THE PROCEDURE, THE OUTER SURFACE BECAME TOO HOT TO HOLD. THE CASE WAS COMPLETED WITH THE SAME ONE. THIS WAS THE FIRST TIME THEY HAD USED IT. WE TRIED TO CHECK WHAT TEMPERATURE HOT WATER WAS PUT IN, BUT DID NOT GET AN ANSWER DUE TO THE COVID-19. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE INNER SURFACE OF THE BOTTLE WAS SEEMED TO BE SCRATCHED (PIC.1). THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4). PRODUCTS AVAILABLE FOR RETURN: 1 BOTTLE. PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591514 ↗
• MalfunctionSep 27, 2022Material Integrity Problem; Material Integrity Problem

  FACILITY; [USER FACILITY] PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: CLIENT USED THIS DEVICE FOR OVER THREE YEARS. THE BOTTLE MOUTH HAS BECOME IRREGULARITY. CUSTOMER UNDERSTAND THAT WILL REDUCE THE BOTTLE HEAT PRESERVATION FUNCTION. BUT IT WAS ALMOST IMPOSSIBLE THAT WARMER BOTTLE LOSES THE FUNCTION TOTALLY. THE WATER IN THIS BOTTLE ONLY KEEPS WARM IN A SHORT TIME RECENTLY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 25JUL2022 VIA EMAIL FROM [NAME], [FACILITY] PURCHASING REPRESENTATIVE. IMAGE OF BOTTLE MOUTH ATTACHED. PATIENT STATUS: BEFORE USE - NA. TYPE OF INTERVENTION: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495002 ↗
• MalfunctionMar 10, 2022Material Integrity Problem; Material Integrity Problem

  PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: TRANSLATION: THERMOS BOTTLE FOR USE IN LAPAROSCOPY. IT IS BROKEN. DOES NOT RETAIN HEAT. FROM COMPLAINT FORM: ACCORDING TO THE OR NURSES, THE HEATED SALINE INSIDE THE SCOPE WARMER GOT COLD TO FAST IN THE LAST TIMES THEY USED IT. THIS SCOPE WARMER HAS, AT LEAST, 3+ YEARS OF DAILY USE; ACCORDING TO HOSPITAL'S INFORMATION, IT'S BROKEN AND DO NOT HOLD THE HEAT AND THEY SENT US A REPAIR ORDER ASKING IF WE CAN CORRECT THE ISSUE. THEY ARE AWARE THAT THIS PRODUCT HAS A LOT OF USE AND IS ALSO SUBJECT TO WEAR AND TEAR. THEY UNDERSTOOD THAT WE DO NOT REPAIR THIS MATERIAL. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726193 ↗
• MalfunctionApr 15, 2021Problem with Sterilization; Problem with Sterilization

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. AFTER TRYING TO STERILIZE THE SCOPE WARMER, SOME LIQUID GOT STUCKED INSIDE. THE HOSPITAL DOESN'T THINK THIS IS THE RIGHT PERFORMANCE OF THE PRODUCT. THEY BOUGHT ANOTHER ONE AND THEY HAVEN'T HAD ANY PROBLEM WITH IT. INTERVENTION: THEY BOUGHT ANOTHER ONE AND THEY HAVEN'T HAD ANY PROBLEM WITH IT. PATIENT STATUS:NO CLINICAL CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673494 ↗
• MalfunctionJul 10, 2020Noise, Audible; Noise, Audible

  NAME OF PROCEDURE: PROSTATECTOMY WITH ROBOT ASSISTANCE. THE RESPONSIBLE NURSE (CADRE DE BLOC), MR. [NAME], TELLS ME THAT THE PRODUCT MAKES A LIQUID NOISE WHEN HANDLED. THIS NOISE HAS ALWAYS BEEN PRESENT (IT WOULD HAVE BEEN BOUGHT IN EARLY 2020). THE PRODUCT HAS ALREADY BEEN USED ON THE BLOCK. CURRENTLY, SURGEONS NO LONGER WISH TO USE IT AS LONG AS THIS NOISE IS PRESENT. NO LIQUID LEAKS DIRECTLY VISIBLE. NO IMPACT ON A PATIENT. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 24JUNE20: NAME OF PROCEDURE BEING PERFORMED: FOR 95% FOR SURGICAL PROCEDURES: PROSTATECTOMY WITH ROBOT ASSISTANCE. THE CANISTER IS RUSTING OR CORRODING. THE BASE DID NOT BREAK. THE CANISTER IS DENTED. THERE IS A PRESENCE OF WATER BETWEEN THE CANISTER WALLS. THE CUSTOMER SPECIFIES HOWEVER THAT THE NOISE OF WATER INSIDE THE DEVICE WAS ALREADY PRESENT DURING ITS DELIVERY. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. TYPE OF INTERVENTION: NI.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10260957 ↗
• MalfunctionMar 6, 2020Nonstandard Device; Nonstandard Device

  PROCEDURE PERFORMED: UNKNOWN. FROM CER FORM: I RECEIVED AN EMAIL FROM CUSTOMER SERVICES ADVISING THE BELOW, WE WERE CONTACTED ON THE 29TH OF JANUARY AND WERE ADVISED THE INCIDENT HAPPENED "LAST WEEK", SO I AM UNSURE OF THE ACTUAL EVENT DATE. "THE HAVE A SCOPE WARMER CT3001 LOT 1320569. THEY HAVE USED IT SINCE PURCHASE, BUT LAST WEEK AFTER IT WASHED IT HAS STARTED TO RATTLE. THEY THINK IT MIGHT THE INSULATION COMING OFF BUT THEY ARE NOT SURE. THEY WANT TO KNOW IF IT'S UNDER WARRANTY." INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9803070 ↗
• MalfunctionDec 11, 2019Material Integrity Problem; Material Integrity Problem

  PROCEDURE PERFORMED: LAP CHOLE. AT BEGINNING OF CASE, SCOPE SEAL WOULD NOT MOUNT ONTO CANISTER. NURSE SAID IT WAS LIP OF CANISTER WAS DEFORMED AND HAD BEEN PROBLEMATIC FOR SOME TIME. AS A RESULT, DURING THE CASE, THE WATER BECAME COLD THEREFORE DEVICE TO SERVE PURPOSE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 25SEP19: I AM AT THE HOSPITAL NOW AND HAVE JUST SPOKEN TO [DEPUTY THEATRE MANAGER]. SHE UNFORTUNATELY CANNOT PROVIDE FURTHER INFORMATION AND THE TWO THEATRE STAFF WHO WERE WORKING THAT DAY ARE NOT HERE. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM APPLIED MEDICAL REPRESENTATIVE ON 27SEP19: YOU CONFIRMED BY PHONE THAT WHEN YOU VISITED THE HOSPITAL, THEY LOOKED AT THE EVENT RECORD AND DID NOT FIND ANY INFORMATION RELATED TO THE PATIENT STATUS FOLLOWING THE INCIDENT. IN CASE THERE WOULD HAVE BEEN ANY CONSEQUENCE ON THE PATIENT, THIS WOULD HAVE BEEN INDICATED IN THE HOSPITAL EVENT RECORD AND COMMUNICATED TO YOU. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 17OCT19: I HAVE SPOKEN TO THE STAFF MEMBER CONCERNED, WHO CONFIRMS THAT THE FLASK LIP WAS DAMAGED/BENT BEFORE THE PROCEDURE. THIS IS AT THE BEGINNING/SET

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9453668 ↗
• MalfunctionAug 19, 2016Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STERILIZATION- "RECENTLY, THE ENDOSCOPE HEATERS AT THIS HOSPITAL BECOME DISTORTED SIGNIFICANTLY AFTER 10 STERILIZATIONS. TO REMOVE THIS PROBLEM, THEY WENT FROM 18 MINUTES STERILIZATION 134 DEGREES TO 125 DEGREES AND THUS AT LESS PRESSURE. BUT THE PHENOMENON PERSISTS. CUSTOMER GAVE ME A COPY WITH THE INTERNAL WALLS OF THE HEATER COMPLETELY DISTORTED AND NOT ALLOWING ITS USE. SIMILARLY THEY FOUND THAT WATER WAS STAGNANT IN THE DOUBLE WALL OF THE ENDOSCOPE HEATER. " ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER RELATIONS: LOT NUMBER IS 1236790. TYPE OF INTERVENTION: "TO REMOVE THIS PROBLEM, THEY WENT FROM 18 MINUTES STERILIZATION 134 DEGREES TO 125 DEGREES AND THUS AT LESS PRESSURE. BUT THE PHENOMENON PERSISTS." PATIENT STATUS: 'UNKNOWN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5891676 ↗