WASHING PIPE PW-5L-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170044458), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 death, 1 injury.

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.

• DeathMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING ARTICLE: "DEMARCATION OF EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA DURING ENDOSCOPIC SUBMUCOSAL DISSECTION: A COMPARISON STUDY BETWEEN LUGOL'S IODINE STAINING AND NARROW-BAND IMAGING."     THIS WAS A SINGLE-CENTER, RETROSPECTIVE, COHORT STUDY WAS AIMED TO INVESTIGATE AND COMPARE THE EFFECTS ON CLINICAL OUTCOMES BETWEEN LUGOL¿S IODINE STAINING (LIS) AND NARROW-BAND IMAGING (NBI) ARE IN THE DEMARCATION OF EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA (EESCCS) DURING ENDOSCOPIC SUBMUCOSAL DISSECTION AND PROVIDE EVIDENCE TO DIRECT FUTURE CLINICAL PRACTICE. A TOTAL OF 172 CONSECUTIVE PATIENTS WERE INCLUDED AND RECEIVED TWO DIFFERENT MARGIN DETERMINATIONS OF THE LESION, LIS (N=109) AND NBI (N=63). DATA ON CLINICAL OUTCOMES, ADVERSE EVENTS, AND FOLLOW-UP INFORMATION WERE COLLECTED FOR ANALYSIS. THE STUDY REVEALED THAT ALL PATIENTS UNDERWENT ESD SUCCESSFULLY WITH A MEAN PROCEDURE TIME OF 52.5±38.1 MINUTES. THE REPORTED RATES FOR EN BLOC AND R0 RESECTION WAS 100% AND 89.5%, RESPECTIVELY. A TOTAL OF 44 (25.6%) PATIENTS SUFFERED ADVERSE EVENTS, INCLUDING 16 (9.3%) PATIENTS WITH IN-HOSPITAL ADVERSE EVENTS AND 39 (22.7%) WITH ESOPHAGEAL STENOSIS. IN CONCLUSION, THE STUD

  Patient problems: Insufficient Information

  MAUDE report 13758910 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING ARTICLE: "DEMARCATION OF EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA DURING ENDOSCOPIC SUBMUCOSAL DISSECTION: A COMPARISON STUDY BETWEEN LUGOL'S IODINE STAINING AND NARROW-BAND IMAGING."     THIS WAS A SINGLE-CENTER, RETROSPECTIVE, COHORT STUDY WAS AIMED TO INVESTIGATE AND COMPARE THE EFFECTS ON CLINICAL OUTCOMES BETWEEN LUGOL¿S IODINE STAINING (LIS) AND NARROW-BAND IMAGING (NBI) ARE IN THE DEMARCATION OF EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA (EESCCS) DURING ENDOSCOPIC SUBMUCOSAL DISSECTION AND PROVIDE EVIDENCE TO DIRECT FUTURE CLINICAL PRACTICE. A TOTAL OF 172 CONSECUTIVE PATIENTS WERE INCLUDED AND RECEIVED TWO DIFFERENT MARGIN DETERMINATIONS OF THE LESION, LIS (N=109) AND NBI (N=63). DATA ON CLINICAL OUTCOMES, ADVERSE EVENTS, AND FOLLOW-UP INFORMATION WERE COLLECTED FOR ANALYSIS. THE STUDY REVEALED THAT ALL PATIENTS UNDERWENT ESD SUCCESSFULLY WITH A MEAN PROCEDURE TIME OF 52.5±38.1 MINUTES. THE REPORTED RATES FOR EN BLOC AND R0 RESECTION WAS 100% AND 89.5%, RESPECTIVELY. A TOTAL OF 44 (25.6%) PATIENTS SUFFERED ADVERSE EVENTS, INCLUDING 16 (9.3%) PATIENTS WITH IN-HOSPITAL ADVERSE EVENTS AND 39 (22.7%) WITH ESOPHAGEAL STENOSIS. IN CONCLUSION, THE STUD

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Perforation; Pleural Effusion; Pneumothorax

  MAUDE report 13758890 ↗