DSD-201 DSD-201 120VRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00677964033858), received between Nov 14, 2016 and Mar 2, 2020 — classified as 22 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K914145); they may or may not involve this specific model.

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2020Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD THEIR BASIN TEMPERATURE SET BELOW THE MINIMUM REQUIREMENT FOR A DSD 201 AUTOMATED ENDOSCOPE REPOCESSOR (AER). THERE IS POTENTIAL THAT ENDOSCOPES WERE NOT ADEQUATELY HIGH LEVEL DISINFECTED.

  Patient problems: No Information

  MAUDE report 9774454 ↗
• InjuryAug 22, 2019Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A BIOMEDICAL TECHNICIAN REPORTED THAT WHILE ON SITE SERVICING A FACILITY'S DSD-201 AUTOMATED ENDOSCOPE PREPROCESSOR (AER), THE BASIN TEMPERATURE OF THE AER HAD THE INCORRECT TEMPERATURE SETTINGS PER THE RAPICIDE HIGH-LEVEL DISINFECTANT BEING USED. THERE IS A POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE AER WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED, THUS THERE IS A POTENTIAL FOR PATIENT HARM.

  Patient problems: No Information

  MAUDE report 8923159 ↗
• InjuryApr 24, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD NOT BEEN USING TEST STRIPS TO TEST THE MINIMUM REQUIRED CONCENTRATION (MRC) OF THE HIGH-LEVEL DISINFECTANT BEFORE EACH REPROCESSING CYCLE IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT THE DISINFECTANT CYCLE DID NOT REACH HIGH-LEVEL DISINFECTION, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8547191 ↗
• InjuryApr 17, 2019Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material

  MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED WHILE ONSITE AT THE FACILITY FOR A SERVICE VISIT THAT THE FACILITY'S DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER), ENDOSCOPES AND HOOKUPS WERE STAINED WITH A GREEN RESIDUE. THERE IS POTENTIAL FOR PATIENT HARM FROM EXPOSURE TO THE GREEN RESIDUE AND POTENTIAL THAT ENDOSCOPES WERE NOT ADEQUATELY HIGH LEVEL DISINFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524712 ↗
• InjuryMar 29, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDIVATORS FIELD SERVICE ENGINEER REPORTED THAT WHILE ON SITE AT A FACILITY PERFORMING MAINTENANCE, HE OBSERVED THE FACILITY USING MODIFIED HOOKUPS AND THE INCORRECT PARAMETER SETS FOR CIDEX OPA IN THE DSD 201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT ENDOSCOPES WERE NOT PROPERLY HIGH-LEVEL DISINFECTED, THUS THERE IS POTENTIAL FOR CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466920 ↗
• InjuryFeb 25, 2019Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material; Mechanics Altered; Failure to Clean Adequately; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material; Mechanics Altered; Failure to Clean Adequately

  MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD BEEN USING EXPIRED TEST STRIPS TO CHECK THE MINIMUM REQUIRED CONCENTRATION OF RAPICIDE HIGH-LEVEL DISINFECTANT (HLD) USED IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE FSE ALSO REPORTED BROWN DISCOLORATION OF THE INTERCEPT DETERGENT USED WITH THEIR AER. ADDITIONALLY, THE FACILITY REMOVED PARTS, DISABLING ONE SIDE OF THEIR DSD-201 AER, AND IS THEREFORE UNABLE TO PERFORM WATER LINE DISINFECTION. THERE IS POTENTIAL FOR CONTAMINATION OR INADEQUATE HLD OF THE ENDOSCOPES PRIOR TO USE IN PATIENT PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8368486 ↗
• InjuryFeb 13, 2019Contamination; Contamination

  MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE ONSITE TO REPAIR THE FACILITY'S DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER), THE FACILITY'S INCOMING WATER CONTAINED A BLACK SUBSTANCE, CAUSING THE 0.2 MICRON INTERNAL FILTER OF THE AER TO TURN BLACK. THE FACILITY REPORTED CHANGING THE FILTER MORE FREQUENTLY DUE TO BUILDUP OF THE UNKNOWN SUBSTANCE. THE FACILITY RECENTLY REPORTED OBSERVING DISCOLORED WATER IN THE BASIN OF THEIR AER. MEDIVATORS HAS ADVISED THE FACILITY TO DISCONTINUE REPROCESSING CYCLES IN THEIR AER UNTIL THE WATER ISSUE IS RESOLVED; HOWEVER, THE FACILITY CONTINUES TO RUN THEIR AER. THERE IS POTENTIAL CONTAMINATION OF THE AER AND ENDOSCOPES DUE TO THE BLACK SUBSTANCE IN THE FACILITY'S WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336708 ↗
• InjuryFeb 12, 2019Flushing Problem; Improper or Incorrect Procedure or Method; Flushing Problem; Improper or Incorrect Procedure or Method

  DURING A SERVICE VISIT, A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD THE INCORRECT WATER LINE DISINFECTION (WLD) CYCLE SETTING FOR THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS A POTENTIAL CONTAMINATION RISK FROM NOT PERFORMING THE WATERLINE DISINFECTION FOR THE REQUIRED AMOUNT OF TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332264 ↗
• InjuryFeb 8, 2019Off-Label Use; Off-Label Use

  MEDIVATORS FIELD SERVICE ENGINEER REPORTED DURING A SERVICE VISIT FOR A FACILITY'S DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER) THAT THE FACILITY WAS USING MAXICIDE PLUS 28 DAY SOLUTION, A HIGH LEVEL DISINFECTANT. MAXICIDE PLUS IS NOT INTENDED FOR USE WITH THE AER, THUS THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE AER WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED AND, THEREFORE, POTENTIAL FOR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8321398 ↗
• InjuryDec 20, 2018Failure to Disinfect; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Failure to Disinfect; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE ON SITE AT THE FACILITY, IT WAS IDENTIFIED THEY WERE NOT FOLLOWING APPROPRIATE ENDOSCOPE MANUAL CLEANING AND REPROCESSING PROCESSES WHICH COULD POTENTIALLY RESULT IN ENDOSCOPES USED IN PATIENT PROCEDURES NOT BEING ADEQUATELY HIGH-LEVEL DISINFECTED.

  Patient problems: Exposure to Body Fluids; No Known Impact Or Consequence To Patient

  MAUDE report 8186430 ↗
• InjuryDec 19, 2018Off-Label Use; Off-Label Use

  MEDIVATORS FIELD SERVICE ENGINEER REPORTED DURING A SERVICE VISIT FOR A FACILITY'S DSD-201 AUTOMATED ENDOSCOPE RE-PROCESSOR, THAT THE AER WAS MODIFIED BY ADDING A SWITCH TO SHUT OFF THE COMPRESSOR. THIS MODIFICATION IS NOT PART OF THE DESIGN SPECIFICATIONS FOR THE AER, THUS THE FACILITY IS USING THE DEVICE OFF-LABEL WHICH COULD PRESENT POTENTIAL USER HARM.

  Patient problems: Electric Shock; No Known Impact Or Consequence To Patient

  MAUDE report 8180582 ↗
• InjuryNov 13, 2018Use of Incorrect Control/Treatment Settings; Off-Label Use; Use of Incorrect Control/Treatment Settings; Off-Label Use

  IT WAS REPORTED THAT A FACILITY WAS REPROCESSING ENDOSCOPES IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER) WITH THE INCORRECT AMOUNT OF RINSES PER THE HIGH-LEVEL DISINFECTANT LABELING AND AER INSTRUCTIONS-FOR-USE. THE FACILITY WAS USING METRICIDE OPA HLD WHICH REQUIRES 3 RINSES BUT THEIR AER WAS SET UP WITH 2 RINSES. THERE IS POTENTIAL THAT ENDOSCOPES MAY HAVE CONTAINED HLD RESIDUAL AFTER REPROCESSING WHICH COULD CAUSE CHEMICAL COLITIS OR ADVERSE REACTIONS TO PATIENTS.

  Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient

  MAUDE report 8063992 ↗
• InjuryNov 2, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A FACILITY REPORTED RESIDUE ON THE FLEXIBLE RUBBER SHEATHS OF EGD ENDOSCOPES AFTER BEING REPROCESSED IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSORS (AERS). THERE IS POTENTIAL FOR PATIENT EXPOSURE TO THE UNKNOWN RESIDUAL IF USED IN SUBSEQUENT PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034920 ↗
• InjurySep 20, 2018Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  MEDIVATORS FIELD SERVICE ENGINEER REPORTED WHILE ON SITE AT A FACILITY SERVICING THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR THAT ONE BASIN OF THE AER HAD THE INCORRECT TEMPERATURE SETTINGS PER THE RAPICIDE HIGH-LEVEL DISINFECTANT BEING USED. THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE AER WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED, THUS THERE IS POTENTIAL FOR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894205 ↗
• InjurySep 12, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDIVATORS CLINICAL EDUCATION SPECIALIST REPORTED THAT WHILE PERFORMING IN-SERVICE TRAINING, A FACILITY WAS USING INCORRECT HOOKUPS AND CHANNEL PLUGS FOR ENDOSCOPES BEING REPROCESSED IN THEIR DSD AUTOMATED ENDOSCOPE REPROCESSORS. THERE IS POTENTIAL THAT ENDOSCOPES WERE NOT PROPERLY HIGH-LEVEL DISINFECTED, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868434 ↗
• InjuryAug 15, 2018Residue After Decontamination; Residue After Decontamination

  A FACILITY REPORTED BLUE RESIDUE ON 3 DIFFERENT ENDOSCOPES AFTER BEING REPROCESSED IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR. IT IS UNKNOWN IF THIS RESIDUE COULD POTENTIALLY CAUSE PATIENT ADVERSE EVENTS SINCE ONE OF THE ENDOSCOPES WITH BLUE RESIDUE WAS USED IN A PROCEDURE.

  Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient

  MAUDE report 7787187 ↗
• InjuryApr 2, 2018Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  A MEDIVATORS FIELD SERVICE ENGINEER WAS AT A FACILITY SERVICING A DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR AND REPORTED THE FACILITY WAS USING THE INCORRECT WATER FILTER WITH THEIR UNIT. THERE IS POTENTIAL FOR MICROBIAL CONTAMINATION TO BE INTRODUCED WHILE REPROCESSING ENDOSCOPES, THUS THERE IS POTENTIAL FOR PATIENT ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390564 ↗
• InjuryFeb 15, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FACILITY REPORTED BLUE FLUID, THE SAME COLOR AS THEIR HIGH LEVEL DISINFECTANT, FOUND ON AN ENDOSCOPE AFTER REPROCESSING IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR. MEDIVATORS FIELD SERVICE ENGINEER FOUND THAT THE FACILITY WAS NOT USING THE COUNTER WEIGHT ON THE DISTAL TIP OF THEIR PEDIATRIC SCOPE, CAUSING THE SCOPE TO SPRAY HLD SOLUTION AROUND THE AER BASIN DURING REPROCESSING. IMPROPER CLEANING OF THE BASIN BETWEEN CYCLES AND NOT FOLLOWING THE SCOPE MANUFACTURER'S INSTRUCTIONS FOR PROPER SCOPE REPROCESSING COULD ALLOW HLD RESIDUALS TO BE INTRODUCED TO PATIENTS AND POTENTIALLY CAUSE CHEMICAL COLITIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274711 ↗
• InjuryJan 17, 2018Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A FACILITY REPORTED THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR WAS PROGRAMMED WITH THE INCORRECT NUMBER OF RINSES REQUIRED FOR USE WITH THE HIGH LEVEL DISINFECTANT BEING USED. INADEQUATE RINSING OF ENDOSCOPES COULD POTENTIALLY CAUSE PATIENT CHEMICAL COLITIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7200127 ↗
• InjuryDec 7, 2017Contamination /Decontamination Problem; Device Contamination With Biological Material; Contamination /Decontamination Problem; Device Contamination With Biological Material

  THE FACILITY REPORTED THAT WHILE PERFORMING AN ENDOSCOPY PROCEDURE, TISSUE WAS FOUND IN THE ENDOSCOPE FROM THE PREVIOUS PATIENT. THIS INDICATES IMPROPER PRE-CLEANING. THERE IS A POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7097990 ↗
• InjuryNov 22, 2017Crack; Leak/Splash; Crack; Leak/Splash

  A FACILITY REQUESTED DECONTAMINATION AND PREVENTATIVE MAINTENANCE (PM) SERVICES FOR THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR. A MEDIVATORS FIELD SERVICE ENGINEER DISCOVERED THAT ALL THREE OF THE FACILITY'S MACHINES HAD MAJOR LEAKS ALONG WITH CRACKED BASINS. AERS WITH DAMAGED BASINS PRESENT A RISK OF BACTERIA AND ORGANISMS AND COULD POTENTIALLY LEAD TO PATIENT HARM. IT WAS REPORTED THAT THE MACHINES WERE IN BAD CONDITION AND WERE NOT APPROPRIATELY MAINTAINED. IT WAS RECOMMENDED BY MEDIVATORS THESE MACHINES BE TAKEN OUT OF SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053675 ↗
• InjuryNov 3, 2017Use of Device Problem; Facilities Issue; Use of Device Problem; Facilities Issue

  MEDIVATORS FIELD SERVICE ENGINEER VISITED THE FACILITY AND DISCOVERED THE SENSORS WITHIN THE UNIT HAD BEEN DISABLED AND THE UNIT WAS NOT PROGRAMMED TO THE CORRECT SETTINGS IN ACCORDANCE WITH THE CHEMISTRY'S INSTRUCTIONS FOR USE. THERE IS POTENTIAL THE ENDOSCOPES REPROCESSED WERE NOT PROPERLY DISINFECTED OR RINSED, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION OR CHEMICAL COLITIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000659 ↗
• Jan 20, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CASE STATES THAT AN ENZYMATIC DETERGENT WAS INADVERTENTLY LOADED INTO THE DISINFECTANT RESERVOIR ON A DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR. IT IS UNKNOWN AS TO WHETHER PATIENT SCOPES WERE RUN, THUS POTENTIAL SCOPES WERE NOT HIGH LEVEL DISINFECTED THEN USED IN A PATIENT PROCEDURE. THERE IS POTENTIAL FOR CROSS CONTAMINATION BETWEEN PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6268686 ↗
• Nov 14, 2016Device Reprocessing Problem; Device Reprocessing Problem

  THE FACILITY IS NOT APPROPRIATELY PRE-CLEANING AND MANUAL CLEANING ENDOSCOPES PRIOR TO REPROCESSING IN THE DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6100763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914145. One submission often covers many models, so check the product and lot details in each record.

• Z-2213-2010 · Jun 15, 2010 · Terminated
  DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the