iDrive INTB100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884523007107), received between Apr 16, 2018 and Jun 14, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, AFTER RESECTING THE COLON IN A COLECTOMY END TO SIDE ANASTOMOSIS PROCEDURE, THE CARTRIDGE WAS RELEASED FROM THE TISSUE. WHEN THE NURSE TRIED TO RETURN THE CARTRIDGE TO NEUTRAL POSITION, THE CARTRIDGE DID NOT STRAIGHTEN. THE INDICATOR FOR THE HANDLE FLASHED GREEN. THE INDICATORS FOR THE ADAPTER AND THE CARTRIDGE WERE ILLUMINATING. THE STATUS INDICATOR FLASHED BLUE. AFTER CHANGING THE BATTERY, THE CARTRIDGE MOVED AS USUAL AND WAS ABLE TO BE DISCONNECTED, SO THE PROCEDURE WAS CONTINUED WITHOUT TAKING FURTHER MEASURES. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700469 ↗
• MalfunctionDec 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. THEY ATTEMPTED TO FIRE THE DEVICE TWICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176687 ↗
• MalfunctionNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, AT THE FIRST FIRING, WHEN THE RELOAD WAS CONNECTED TO THE POWER HANDLE, THE JAWS WERE ABLE TO BE CLOSED, BUT THE JAWS WERE UNABLE TO BE OPENED. THE RELOAD WAS TAKEN OUT BY FORCE AND A NEW PRODUCT WAS USED. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8094835 ↗
• MalfunctionOct 31, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, AT THE FIRST FIRING, THE SURGEON CLAMPED THE TISSUE, AND HE COULD NOT FIRE THE DEVICE. THEY REPLACED THE RELOAD AND THE FIRING WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8024511 ↗
• MalfunctionOct 30, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A BARIATRIC SURGERY, WHILE PERFORMING THE GASTRIC BYPASS, THE LOAD CAUGHT AND DID NOT FIRE. THE RELOAD WAS REPLACED BY ANOTHER AND RAN SMOOTHLY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019728 ↗
• MalfunctionJul 30, 2018Charging Problem

  ACCORDING TO THE REPORTER, THEY INSERTED THE BATTERY TO CHARGER ALL THROUGH THE NIGHT, HOWEVER THE CHARGE WAS NOT COMPLETED. THE CHARGE STATUS INDICATOR KEPT FLASHING. THE EVENT OCCURRED OUT OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7731090 ↗
• MalfunctionJun 7, 2018Difficult to Open or Close; Premature Indicator Activation; Difficult to Open or Close; Premature Indicator Activation

  ACCORDING TO THE REPORTER, FOR THE FIRST FIRING IN A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THEY SET THE DEVICE AND CONNECTED THE CARTRIDGE WITH NO PROBLEM. THEY CHECKED THE JAWS OPENING/CLOSING AND ARTICULATION THEN THE SURGEON INSERTED THE DEVICE TO THE CAVITY; HOWEVER, THE STATUS INDICATOR FLASHED GREEN EVEN THOUGH THE GREEN FIRING MODE BUTTON WAS NOT TOUCHED AND THE JAWS DID NOT REACT EVEN THOUGH THE SILVER BUTTON WAS PUSHED. REPLACED BY ANOTHER BATTERY, THEY COULD REMOVE THE CARTRIDGE FROM THE ADAPTER. THEN THEY CONNECTED A NEW CARTRIDGE TO THE SAME ADAPTER; HOWEVER, THE STATUS INDICATOR ILLUMINATED BLUE AND THE GREEN INDICATOR ILLUMINATED, AND THE DEVICE DID NOT REACT AT ALL. REPLACED BY A MANUAL HANDLE, AND THE PROCEDURE WAS CONTINUED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7577780 ↗
• MalfunctionApr 16, 2018Power Problem; Power Problem

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION OF RECTUM, WHILE PERFORMING DOUBLE STAPLING, THE DEVICE STOPPED WORKING WHILE CLAMPING TISSUE ON THE FIRST FIRING. THE BATTERY WAS RESET TO REMOVE THE DEVICE FROM THE TISSUE, THEN REASSEMBLED THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7433111 ↗