GRASPING FORCEPS FG-48L-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170032387), received between Nov 15, 2022 and Nov 15, 2022 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF A SECOND ENDOSCOPIC ARM TO IMPROVE THERAPEUTIC ENDOSCOPY IN THE LOWER GASTROINTESTINAL TRACT. PRELIMINARY EXPERIENCE ¿ A CASE SERIES". THE AIM OF OUR STUDY WAS TO TEST THE FEASIBILITY OF UTILIZING A SECOND ENDOSCOPIC ARM TO EXERT COUNTER-TRACTION TO LIFT THE LESION AWAY FROM THE CUTTING PLANE, AMELIORATING SUBMUCOSAL EXPOSURE. TOTAL EIGHT PATIENTS WERE INCLUDED IN THIS STUDY. THREE COMPLICATIONS OCCURRED AND WERE MANAGED ENDOSCOPICALLY. ONE PATIENT EXPERIENCED A SMALL PERFORATION IN THE SIGMOID COLON. TWO PATIENTS PRESENTED WITH DELAYED BLEEDING. APPLYING COUNTER-TRACTION WITH A SECOND ENDOSCOPIC ARM CAN FACILITATE SUBMUCOSAL DISSECTION OF DISTAL COLORECTAL LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION - 1 PATIENT. DELAYED BLEEDING - 2 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 9 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) FOR FG-48L-1, PT #4: PERFORATION. (B)(6) FOR CF-Q165I, PT #4: PERFORATION. (B)(6) FOR FG-46U-1, PT #4: PERFORATION. (B)(6) FOR FG-48L-1, PT #5: DELAYED BLEEDING. (B)(6) FOR CF-Q165I, PT #5: DELAYED BLEEDING. (B)(6) FOR FG-46U-1, PT #5: DELAYED BLEEDING. (B)(6) FO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15802355 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF A SECOND ENDOSCOPIC ARM TO IMPROVE THERAPEUTIC ENDOSCOPY IN THE LOWER GASTROINTESTINAL TRACT. PRELIMINARY EXPERIENCE ¿ A CASE SERIES". THE AIM OF OUR STUDY WAS TO TEST THE FEASIBILITY OF UTILIZING A SECOND ENDOSCOPIC ARM TO EXERT COUNTER-TRACTION TO LIFT THE LESION AWAY FROM THE CUTTING PLANE, AMELIORATING SUBMUCOSAL EXPOSURE. TOTAL EIGHT PATIENTS WERE INCLUDED IN THIS STUDY. THREE COMPLICATIONS OCCURRED AND WERE MANAGED ENDOSCOPICALLY. ONE PATIENT EXPERIENCED A SMALL PERFORATION IN THE SIGMOID COLON. TWO PATIENTS PRESENTED WITH DELAYED BLEEDING. APPLYING COUNTER-TRACTION WITH A SECOND ENDOSCOPIC ARM CAN FACILITATE SUBMUCOSAL DISSECTION OF DISTAL COLORECTAL LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION - 1 PATIENT. DELAYED BLEEDING - 2 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 9 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6) FOR FG-48L-1, PT #4: PERFORATION. 2. (B)(6) FOR CF-Q165I, PT #4: PERFORATION. 3. (B)(6) FOR FG-46U-1, PT #4: PERFORATION. 4. (B)(6) FOR FG-48L-1, PT #5: DELAYED BLEEDING. 5. (B)(6) FOR CF-Q165I, PT #5: DELAYED BLEEDING. 6. (B)(6) FOR FG-46U-1, PT #5: DELAYED B

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15802274 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF A SECOND ENDOSCOPIC ARM TO IMPROVE THERAPEUTIC ENDOSCOPY IN THE LOWER GASTROINTESTINAL TRACT. PRELIMINARY EXPERIENCE ¿ A CASE SERIES". THE AIM OF OUR STUDY WAS TO TEST THE FEASIBILITY OF UTILIZING A SECOND ENDOSCOPIC ARM TO EXERT COUNTER-TRACTION TO LIFT THE LESION AWAY FROM THE CUTTING PLANE, AMELIORATING SUBMUCOSAL EXPOSURE. TOTAL EIGHT PATIENTS WERE INCLUDED IN THIS STUDY. THREE COMPLICATIONS OCCURRED AND WERE MANAGED ENDOSCOPICALLY. ONE PATIENT EXPERIENCED A SMALL PERFORATION IN THE SIGMOID COLON. TWO PATIENTS PRESENTED WITH DELAYED BLEEDING. APPLYING COUNTER-TRACTION WITH A SECOND ENDOSCOPIC ARM CAN FACILITATE SUBMUCOSAL DISSECTION OF DISTAL COLORECTAL LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION - 1 PATIENT. DELAYED BLEEDING - 2 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 9 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6) FOR FG-48L-1, PT #4: PERFORATION; 2. (B)(6) FOR CF-Q165I, PT #4: PERFORATION; 3. (B)(6) FOR FG-46U-1 , PT #4: PERFORATION; 4. (B)(6) FOR FG-48L-1 , PT #5: DELAYED BLEEDING; 5. (B)(6) FOR CF-Q165I , PT #5: DELAYED BLEEDING; 6. (B)(6) FOR FG-46U-1 , PT #5: DELAY

  Patient problems: Bowel Perforation

  MAUDE report 15802161 ↗