SSD-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00677964035647), received between Dec 14, 2017 and May 3, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2019Off-Label Use; Off-Label Use

  A FACILITY REPORTED ATTEMPTING TO LOAD AN INCORRECT CHEMISTRY, RAPICIDE PA HIGH LEVEL DISINFECTANT (HLD), IN THEIR SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). ADDITIONALLY, THE SCOPE TECHNICIAN LOADING THE CHEMISTRY WAS EXPOSED TO RAPICIDE PA HLD ON THE RIGHT HAND AND LEFT ARM. RAPICIDE PA IS NOT FOR USE WITH THE SSD-201 AER, THEREFORE, THE FACILITY WAS NOT USING THEIR AER IN ACCORDANCE WITH THE AER INSTRUCTIONS FOR USE. THUS, THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE AER WERE NOT APPROPRIATELY HIGH-LEVEL DISINFECTED AND, THEREFORE, POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579728 ↗
• InjurySep 21, 2018Residue After Decontamination; No Apparent Adverse Event; Residue After Decontamination; No Apparent Adverse Event

  THE FACILITY REPORTED THEIR SSD 102 AUTOMATED ENDOSCOPE REPROCESSOR (AER) HAD BLUE DROPLETS LEFT IN THE BASIN AFTER THE REPROCESSING AND AIR PURGE CYCLES. THERE IS POTENTIAL RISK FOR HIGH LEVEL DISINFECTANT RESIDUALS LEFT IN THE ENDOSCOPE THUS POTENTIAL CHEMICAL COLITIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899931 ↗
• InjuryDec 14, 2017Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  MEDIVATORS CLINICAL EDUCATION SPECIALIST WAS AT THE FACILITY PERFORMING AN IN SERVICE WHEN HE NOTICED THE FACILITY WAS USING RAPICIDE GLUTARALDEHYDE HIGH LEVEL DISINFECTANT WITH THEIR SSD-102 AUTOMATED ENDOSCOPE REPROCESSOR. THE FACILITY USUALLY REPROCESSES ENDOSCOPES USING RAPICIDE OPA HIGH LEVEL DISINFECTANT. RAPICIDE GLUTARALDEHYDE AND RAPICIDE OPA REQUIRE DIFFERENT TEST STRIPS AND AER SETTINGS. THE FACILITY CONTINUED TO USE RAPICIDE OPA TEST STRIPS AND SETTINGS WITH RAPICIDE GLUTARALDEHYDE HLD. THE FACILITY WAS NOT REPROCESSING ENDOSCOPES IN ACCORDANCE WITH THE AER'S IFU AND THERE IS POTENTIAL HIGH LEVEL DISINFECTION OF THE ENDOSCOPES WAS NOT REACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119147 ↗

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