GRASPING FORCEPS FG-8U-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170031519), received between Mar 3, 2021 and Apr 12, 2023 — classified as 4 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 16, 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.

• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE DUODENAL LATERALLY SPREADING LESIONS IS FEASIBLE: A MULTI-CENTER RETROSPECTIVE STUDY". THIS MULTICENTRIC RETROSPECTIVE STUDY SOUGHT TO ASSESS THE EFFECT AND SAFETY OF ESD FOR LARGE LATERALLY SPREADING LESIONS LOCATED IN THE DESCENDING DUODENUM BASED ON MULTI-CENTER EXPERIENCES. A TOTAL OF 51 PATIENTS WERE INCLUDED. THE AVERAGE PROCEDURE TIME FOR EN BLOC RESECTION RANGING FROM 20 TO 117 MIN (MEDIAN: 45.5 MIN). TWO PATIENTS EXPERIENCED DELAYED BLEEDING 3 DAYS AFTER ESD AND 2 OTHER PATIENTS WERE DIAGNOSED WITH DELAYED PERFORATION. ALL THE PATIENTS WERE CLOSELY FOLLOWED UP FOR A MEDIAN PERIOD OF 16 MONTHS (RANGE 7 TO 29 MONTHS), AND THERE WERE NO DEATHS. NO RESIDUAL TUMOR AND LOCAL RECURRENCE OCCURRED DURING FOLLOW-UP. ESD FOR LATERALLY SPREADING LESIONS OF THE DESCENDING DUODENUM IS A FEASIBLE THERAPEUTIC PROCEDURE AND CAN ACHIEVE A FAVORABLE EN BLOC RESECTION RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING: CASE 1. DELAYED BLEEDING: CASE 2. DELAYED PERFORATION (POSTOPERATIVE FEVER, MILD ABDOMINAL PAIN): CASE 3. DELAYED PERFORATION (FEVER, SEVERE ABDOMINAL PAIN, DIFFUSE PERIT

  Patient problems: Abdominal Pain; Fever; Perforation; Peritonitis

  MAUDE report 16728019 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE DUODENAL LATERALLY SPREADING LESIONS IS FEASIBLE: A MULTI-CENTER RETROSPECTIVE STUDY". THIS MULTICENTRIC RETROSPECTIVE STUDY SOUGHT TO ASSESS THE EFFECT AND SAFETY OF ESD FOR LARGE LATERALLY SPREADING LESIONS LOCATED IN THE DESCENDING DUODENUM BASED ON MULTI-CENTER EXPERIENCES. A TOTAL OF 51 PATIENTS WERE INCLUDED. THE AVERAGE PROCEDURE TIME FOR EN BLOC RESECTION RANGING FROM 20 TO 117 MIN (MEDIAN: 45.5 MIN). TWO PATIENTS EXPERIENCED DELAYED BLEEDING 3 DAYS AFTER ESD AND 2 OTHER PATIENTS WERE DIAGNOSED WITH DELAYED PERFORATION. ALL THE PATIENTS WERE CLOSELY FOLLOWED UP FOR A MEDIAN PERIOD OF 16 MONTHS (RANGE 7 TO 29 MONTHS), AND THERE WERE NO DEATHS. NO RESIDUAL TUMOR AND LOCAL RECURRENCE OCCURRED DURING FOLLOW-UP. ESD FOR LATERALLY SPREADING LESIONS OF THE DESCENDING DUODENUM IS A FEASIBLE THERAPEUTIC PROCEDURE AND CAN ACHIEVE A FAVORABLE EN BLOC RESECTION RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ DELAYED BLEEDING: CASE 1 DELAYED BLEEDING: CASE 2 DELAYED PERFORATION (POSTOPERATIVE FEVER, MILD ABDOMINAL PAIN): CASE 3 DELAYED PERFORATION (FEVER, SEVERE ABDOMINAL PAIN, DIFFUSE PERITONI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16723727 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE DUODENAL LATERALLY SPREADING LESIONS IS FEASIBLE: A MULTI-CENTER RETROSPECTIVE STUDY". THIS MULTICENTRIC RETROSPECTIVE STUDY SOUGHT TO ASSESS THE EFFECT AND SAFETY OF ESD FOR LARGE LATERALLY SPREADING LESIONS LOCATED IN THE DESCENDING DUODENUM BASED ON MULTI-CENTER EXPERIENCES. A TOTAL OF 51 PATIENTS WERE INCLUDED. THE AVERAGE PROCEDURE TIME FOR EN BLOC RESECTION RANGING FROM 20 TO 117 MIN (MEDIAN: 45.5 MIN). TWO PATIENTS EXPERIENCED DELAYED BLEEDING 3 DAYS AFTER ESD AND 2 OTHER PATIENTS WERE DIAGNOSED WITH DELAYED PERFORATION. ALL THE PATIENTS WERE CLOSELY FOLLOWED UP FOR A MEDIAN PERIOD OF 16 MONTHS (RANGE 7 TO 29 MONTHS), AND THERE WERE NO DEATHS. NO RESIDUAL TUMOR AND LOCAL RECURRENCE OCCURRED DURING FOLLOW-UP. ESD FOR LATERALLY SPREADING LESIONS OF THE DESCENDING DUODENUM IS A FEASIBLE THERAPEUTIC PROCEDURE AND CAN ACHIEVE A FAVORABLE EN BLOC RESECTION RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING: CASE 1; DELAYED BLEEDING: CASE 2; DELAYED PERFORATION (POSTOPERATIVE FEVER, MILD ABDOMINAL PAIN): CASE 3; DELAYED PERFORATION (FEVER, SEVERE ABDOMINAL PAIN, DIFFUSE PERIT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16721446 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 15, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "ENDOSCOPIC FULL-THICKNESS RESECTION WITH DEFECT CLOSURE USING CLIPS AND AN ENDOLOOP FOR GASTRIC SUBEPITHELIAL TUMORS ARISING FROM THE MUSCULARIS PROPRIA". THIS STUDY WAS CONDUCTED ON THE ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR 51 PATIENTS WITH GASTRIC SUBEPITHELIAL TUMORS ARISING FROM THE MUSCULARIS PROPRIA FROM JANUARY 2009 TO DECEMBER 2012. IN THE LITERATURE, IT WAS REPORTED THAT ONE MINOR BLEEDING AND ONE TUMOR FELL INTO THE PERITONEAL CAVITY DURING THE PROCEDURE. THE MINOR BLEEDING WAS SUCCESSFULLY MANAGED BY ENDOSCOPIC MEANS. HOWEVER, IN THE CASE OF THE TUMOR FELL INTO THE PERITONEAL CAVITY, THE PROCEDURE WAS CONVERTED INTO A LAPAROSCOPIC RESECTION. OMSC ASSUMES THAT THE REPORTED EVENTS MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE EFTR. THEREFORE, OMSC ASSUMES THAT THE EVENT CONVERTED INTO A LAPAROSCOPIC RESECTION WAS AN ADVERSE EVENT TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE

  Patient problems: Perforation

  MAUDE report 11408492 ↗