Soehendra G21860Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002218604), received between Jul 21, 2017 and Mar 13, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Off-Label Use

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. IT WAS REPORTED THAT THE CUSTOMER WAS USING THE DEVICE, OUTSIDE OF THE INTENDED USE. THE DEVICE WAS USED TO REMOVE AN ERODED, ADJUSTABLE, GASTRIC BAND. DURING THIS ATTEMPT TO REMOVE THE BAND THE HANDLE BROKE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593677 ↗
• MalfunctionOct 11, 2022Break; Break

  DURING AN ERCP IN THE DUODENUM AND DUCTUS CHOLEDOCHUS, THE PHYSICIAN USED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. IT WAS REPORTED THAT THE HANDLE OF THE HANDLE [DEVICE] BROKE OFF DURING THE LITHOTRIPSY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575128 ↗
• MalfunctionJan 5, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IN PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE USER SELECTED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE AT THE PREPARATION STAGE AND FOUND THAT THE HANDLE COULD NOT PREVENT BACKSPIN. THE PHYSICIAN RETRACTED THE BASKET AND CHANGED TO ANOTHER BASKET WHICH DID NOT NEED A LITHOTRIPTOR TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169098 ↗
• MalfunctionOct 11, 2019Fracture; Fracture

  PRIOR TO AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. WHEN DISINFECTING THE HANDLE WITH A WIPE TISSUE, THE METAL ROD LOCATED ON THE SIDE CAME OUT FROM ITS POSITION. IN TRYING TO PUT IT BACK IN PLACE THE HANDLE BROKE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9179815 ↗
• MalfunctionOct 3, 2019Break; Break

  DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. THE USER FOUND OUT THAT THE HANDLE WAS BROKEN DURING LITHOTRIPSY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9154072 ↗
• MalfunctionDec 11, 2018Material Twisted/Bent; Material Twisted/Bent

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. THIS IS A DEMONSTRATION SET. DURING AN IN-SERVICE, AFTER SHOWING HOW TO RELEASE THE BASKET'S WIRE, THE RATCHET WAS NOT WORKING ANYMORE (THERE WAS NO REPORTABLE INFORMATION AT THIS TIME). ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2018: THE LITHOTRIPSY HANDLE IS SUPPOSED TO MOVE IN ONE DIRECTION WHEN WE CRANK THE HANDLE. AFTER WE BREAK THE ¿PSEUDO STONE¿, WE CAN USE THE QUICK RELEASE RATCHET TO REMOVE THE BASKET FROM THE HANDLE. IN THIS CASE, AFTER USING THE QUICK RELEASE RATCHET, THE SPRING CAME OUT OF ITS POSITION CAUSING THE HANDLE TO MOVE IN BOTH DIRECTIONS WHEN WE CRANKED [THE HANDLE]. WE TRIED TO FIX THE SPRING BACK TO ITS ORIGINAL POSITION BUT IT STILL WILL NOT WORK. THIS OCCURRED DURING A PRODUCT DEMONSTRATION; A PATIENT WAS NOT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8151616 ↗
• MalfunctionNov 30, 2018Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. THE CUSTOMER USED THE SOEHENDRA LITHOTRIPTOR HANDLE WITH COOK CONQUEST TTCL LITHOTRIPTOR CABLE (TTCL-1) AND OTHER MANUFACTURER'S BASKET CATHETER TO CRUSH AND RETRIEVE THE INCARCERATED BILE DUCT STONE, BUT THE HANDLE BENT DURING CRUSHING THE STONE AND BECAME UNUSABLE. THE CUSTOMER MOVED THE BASKET UP AND DOWN, AND LEFT AND RIGHT TO MAKE THE STONE COME OFF FROM THE BASKET, AND REMOVED THE DEVICES FROM THE PATIENT. THE AREA REPRESENTATIVE INDICATED THE USER USED AN INCOMPATIBLE BASKET. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8120271 ↗
• MalfunctionJun 12, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A DEMONSTRATION, THE DISTRIBUTOR REPRESENTATIVE SELECTED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. THE DISTRIBUTOR REPRESENTATIVE PERFORMED A TRAINING TO THE USER FACILITY ON HOW TO USE THE SOEHENDRA LITHOTRIPTOR HANDLE (SLH-1). DURING THE TRAINING, THE DISTRIBUTOR REPRESENTATIVE OPERATED THE DEVICE AND FOUND THAT THE HANDLE DID NOT WORK PROPERLY. THE COMPONENT, NEXT TO THE RATCHET, WAS NOT IN THE RIGHT POSITION. ADDITIONAL INFORMATION WAS RECEIVED ON 06/12/2018: THIS SOEHENDRA LITHOTRIPTOR HANDLE (SLH-1) WAS STOCK AND SOLD TOGETHER WITH A COOK CONQUEST TTC LITHOTRIPTOR CABLE (TTCL-10) TO THE HOSPITAL. THE FAILURE HAPPENED ON A TRIAL USE, BEFORE THE ACADEMIC MEETING LIVE OPERATION DEMONSTRATION. IN THE TRIAL USE, THE DOCTORS AND NURSES WANTED TO PRACTICE THE LITHOTRIPSY PROCEDURE, AND THE REVERSE ROTATING STOP WAS FOUND NOT IN NORMAL FUNCTION. BEFORE THE TRIAL, THE SLH-1 HANDLE WAS IN ITS ORIGINAL PACKAGE, UNOPENED. THEY DON'T KNOW WHY THE GOLD COATING WAS SLIGHTLY WORN, THIS MAY BECAUSE OF IMPROPER STORE OR DELIVERY CONDITION, AS THIS PRODUCT, EVEN IN THE INTACT PACKAGE, HAS BEEN SHOWN TO SEVERAL CUSTOMERS BEFORE SELLING IT.

  Patient problems: No Patient Involvement

  MAUDE report 7590846 ↗
• MalfunctionAug 9, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK SOEHENDRA LITHOTRIPTOR HANDLE. THE USER ROTATED THE HANDLE OF SLH-1 TO CRUSH THE STONES, BUT THE HANDLE OF SLH-1 WAS BROKEN. [THE USER] REPLACED [WITH A] OLYMPUS DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776754 ↗
• MalfunctionJul 21, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK SOEHENDRA LITHOTRIPTOR HANDLE (SLH-1). THE USER ADVANCED THE COOK MEMORY SOFT WIRE BASKET (MSB-2X4) DEVICE INTO LOWER SEGMENT OF COMMON BILE DUCT AND FETCHED THE STONE. BUT THE STONE COULD NOT GO THROUGH THE DUODENAL PAPILLA. THEN THEY INTRODUCED THE BASKET TO MIDDLE PART OF COMMON BILE DUCT AND CUT THE HANDLE PART OF THE BASKET. PULL OUT THE PLASTIC SHEATH. THEY ADVANCED THE COOK CONQUEST TTC LITHOTRIPTER CABLE (TTCL-1) ALONG THE WIRE OF THE BASKET. THEN ROTATED THE HANDLE OF SLH-1 TO CRUSH THE STONES. BUT, THE HANDLE OF THE SLH-1 WAS DETACHED [BROKE]. REPLACE [WITH A] NEW DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731469 ↗