Single Use Repositionable Clip HX-202LR (UDI 04953170385926)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170385926), received between May 10, 2022 and Mar 14, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. May 4, 2023Open, Classified

   Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

   Z-1988-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED PROCEDURE WHILE USING THE SINGLE USE RELOADABLE CLIP APPLICATOR, THE CLIP WAS UNABLE TO BE RELEASED DURING IMPLANTATION. WHEN PULLING ON THE PLIERS, THE CLIP DETACHED FROM THE WALL. THE CLIP AND TIP ASSEMBLY OF THE PLIERS DETACHED FROM THE ROD AND REMAINED IN THE PATIENT'S CAVITY. THE USE OF A SECOND FORCEPS WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED MULTIPLE TIMES BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539138 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE FOR DUODENAL NEUROENDOCRINE TUMORS". LITERATURE SUMMARY: THIS STUDY EXAMINED THE TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE (EMR-L) FOR THE REMOVAL OF DUODENAL NETS LOCATED IN THE SUBMUCOSAL LAYER WITHOUT METASTASIS. EMR-L CAN BE PERFORMED WITH LESS TECHNICAL SKILL, AND THE LIGATION DEVICE REDUCES THE RATE OF POSITIVE VERTICAL MARGIN. THE EN BLOC RESECTION RATE AND ENDOSCOPIC COMPLETE RESECTION RATE WERE BOTH (B)(4). COMPLETE RESECTION WAS ACHIEVED PATHOLOGICALLY IN 7 LESIONS ((B)(4)). THE VERTICAL MARGINS WERE NEGATIVE IN ALL CASES. LYMPHATIC VESSEL INVASION WAS OBSERVED IN THREE PATIENTS, ALL OF WHOM UNDERWENT ADDITIONAL SURGERY WITH LYMPH NODE DISSECTION (ONE OF THEM ALSO EXHIBITED BLOOD VESSEL INVASION AND A POSITIVE HORIZONTAL MARGIN). NO EVIDENCE OF RESIDUAL TUMORS OR LYMPH NODE METASTASIS WAS OBSERVED IN ANY OF THE PATIENTS. NO RECURRENCE WAS OBSERVED IN ANY OF THE 10 PATIENTS (MEAN FOLLOW-UP PERIOD: 18.6 MONTHS). ONE PATIENT (10.0%) EXPERIENCED INTRAOPERATIVE BLEEDING. PERFORATION OCCURRED IN 1 PATIENT (10.0%), BUT THE COND

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14346458 ↗