Short Clip HX-610-090S (UDI 04953170200335)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170200335), received between Dec 21, 2022 and Aug 21, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE SHORT CLIP WAS STUCK INSIDE OF THE FORCEPS CHANNEL. THE REPORTED ISSUE WAS DISCOVERED DURING A DIAGNOSTIC LOWER ENDOSCOPY PROCEDURE. THE SUCTION BUTTON WAS REPLACED BECAUSE IT BECAME DIFFICULT TO SUCTION DURING THE PROCEDURE WHEN IT WAS DISCOVERED THAT A CLIP WAS STUCK INSIDE OF THE CHANNEL. THE CUSTOMER INDICATED THAT A CLIP WAS NOT USED DURING THIS PROCEDURE AND THAT THE LAST TIME THE CLIP WAS USED IN THE ENDOSCOPE WAS DURING PROCEDURES ON (B)(6) 2023. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584404 ↗
• MalfunctionAug 18, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE SHORT CLIP WAS STUCK INSIDE OF THE FORCEPS CHANNEL. THE REPORTED ISSUE WAS DISCOVERED DURING A DIAGNOSTIC LOWER ENDOSCOPY PROCEDURE. THE SUCTION BUTTON WAS REPLACED BECAUSE IT BECAME DIFFICULT TO SUCTION DURING THE PROCEDURE WHEN IT WAS DISCOVERED THAT A CLIP WAS STUCK INSIDE OF THE CHANNEL. THE CUSTOMER INDICATED THAT A CLIP WAS NOT USED DURING THIS PROCEDURE AND THAT THE LAST TIME THE CLIP WAS USED IN THE ENDOSCOPE WAS DURING PROCEDURES ON (B)(6) 2023. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576475 ↗
• MalfunctionAug 18, 2023Device Reprocessing Problem; Off-Label Use; Device Reprocessing Problem; Off-Label Use

  THE SUCTION BUTTON WAS REPLACED BECAUSE IT BECAME DIFFICULT TO SUCTION DURING THE PROCEDURE WHEN IT WAS DISCOVERED THAT A CLIP WAS STUCK INSIDE OF THE CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17575608 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "EFFICACY OF THE POCKET-CREATION METHOD WITH A TRACTION DEVICE IN ENDOSCOPIC SUBMUCOSAL DISSECTION FOR RESIDUAL OR RECURRENT COLORECTAL LESIONS". LITERATURE SUMMARY: THIS STUDY AIMED TO COMPARE THE EFFICACY OF THE POCKET-CREATION METHOD (PCM) WITH A TRACTION DEVICE (TD) WITH THAT OF CONVENTIONAL ESD FOR RESIDUAL OR RECURRENT COLORECTAL LESIONS IN 72 PATIENTS. THE PRIMARY ENDPOINTS WERE EN BLOC RESECTION AND R0 RESECTION RATES. EN BLOC RESECTION WAS FEASIBLE IN ALL CASES WITH PCM WITH TD BUT FAILED IN 22% OF CASES OF CONVENTIONAL ESD. THE R0 RESECTION RATES FOR PCM WITH TD AND CONVENTIONAL ESD WERE 97% AND 66%, RESPECTIVELY. DISSECTION WAS SIGNIFICANTLY FASTER IN THE PCM WITH TD GROUP (13.0 VS. 7.9 MM2/MIN). THIS STUDY CONCLUDES THAT THE PCM WITH TD IS AN EFFECTIVE METHOD FOR TREATING RESIDUAL OR RECURRENT COLORECTAL LESIONS AFTER INCOMPLETE RESECTION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [CONTROL GROUP]. PERFORATION - 1 PATIENT. POST-PROCEDURAL BLEEDING - 1 PATIENT. [PCM WITH TD GROUP]. PERFORATION - 1 PATIENT. POST-PROCEDURAL BLEEDING - 1 PATIENT. ------------------------------------------ SINCE THE LITERATURE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16031199 ↗