Clip HX-610-090 (REF N1085530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170200298), received between May 12, 2023 and Jul 26, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN

  Patient problems: Fever; Peritonitis; Pneumoperitoneum

  MAUDE report 19844508 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN

  Patient problems: Perforation

  MAUDE report 19843857 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS: A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO I

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19838976 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED: "INDICATIONS FOR DENTAL FLOSS CLIP TRACTION DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BY LESS-EXPERIENCED ENDOSCOPISTS." THIS RETROSPECTIVE STUDY INVESTIGATED THE INDICATIONS OF DENTAL FLOSS CLIP (DFC) IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED BY LESS-EXPERIENCED ENDOSCOPISTS FOR EARLY GASTRIC CANCER. A TOTAL OF 812 PATIENTS WERE INCLUDED. THE PROCEDURE TIME IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP (95±46 VS. 75±31, P<0.01). THE PROCEDURE TIME FOR LESIONS LOCATED IN THE GREATER CURVATURE OF THE UPPER OR MIDDLE STOMACH AND LESIONS >20 MM LOCATED IN THE LESSER CURVATURE SIDE OF THE STOMACH IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING - 30 PATIENTS, PERFORATION - 10 PATIENTS. DELAYED BLEEDING WAS DEFINED AS CLINICAL BLEEDING AFTER ESD THAT REQUIRED BLOOD TRANSFUSION OR ENDOSCOPIC OR SURGICAL INTERVENTION. PERFORATION WAS DIAGNOSED WHEN MESENTERIC FAT OR INTRA-ABDOMINAL SPACE WAS OBSERVED DURING THE PROCEDURE OR WHEN FREE AIR WAS IDENTIFIED ON SIMPLE CHEST AND ABDOMINAL RADIOGRAPHS AFTER ESD. RELATED P

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18515230 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION OF GASTRIC NEOPLASIA: A RANDOMIZED CONTROLLED TRIAL". THIS MULTICENTER, RANDOMIZED CONTROLLED TRIAL AIMED TO ASSESS THE EFFICACY OF CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE (CSM-PLT) IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 378 PATIENTS WERE FINALLY INCLUDED IN THE PER-PROTOCOL ANALYSIS. THE MEAN PROCEDURE TIMES WERE 69.7 AND 58.0 MIN FOR THE CONVENTIONAL ESD AND CSM-PLT GROUPS, INDICATING THAT THE PROCEDURE WAS SIGNIFICANTLY SHORTER IN THE CSM-PLT GROUP (P=0.009). THE R0 RESECTION RATE TENDED TO BE HIGHER IN THE CSM PLT GROUP THAN IN THE CONVENTIONAL ESD GROUP (P=0.09). THE MEAN PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE NOVICE (P=0.04), TUMOR SIZE =20 MM (P=0.02), AND IT KNIFE (P=0.045) GROUPS. THE MEAN PREPARATION TIME FOR CSM-PLT WAS 2.3 MIN. CSM-PLT METHOD SHORTENED THE ESD PROCEDURE TIME. MOREOVER, CSM-PLT IS SAFE, DOES NOT INCREASE COMPLICATION RATES, AND IS ASSOCIATED WITH BETTER R0 RESECTION RATES THAN CONVENTIONAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PERFORATION - 5.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16918130 ↗