MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V437QR-30

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2022

Event Type  Injury  

Event Description

It is reported in the literature titled" "case report: a case of biliary bougie response to a fitted basket forceps for treatment of common bile duct stones," a lithocrush was difficult to remove.An 80-year-old man was admitted to our hospital with a diagnosis of choledocholithiasis and underwent endoscopic retrograde cholangiopancreatography.Stone removal with a basket failed and the wires of the basket fractured and impacted in the common bile duct, together with the stone.The patient was referred to our department because of the difficulty of retrieval of the impacted basket from the common bile duct.Open surgery was performed, in which we first tried to remove the basket through a longitudinal choledochotomy, but this was unsuccessful.Next, a papillary bougienage was performed and the basket was successfully released.A t-tube was inserted and the choledochotomy was closed.Impaction of the basket during endoscopic removal of common bile duct stones occurs in 0.8-5.9% of cases.In these cases, papillary bougienage may be a safe and effective method for basket removal.Summary of events as follows: on the 6th day of admission, ercp was performed, and endoscopic sphincterotomy (est) and lithotripsy were attempted using lithotripsy basket forceps (437+ crusher olympas litho crush 437).The physician attempted to grasp the stone and crush it, but the wire remained stuck in the stone, making it difficult to remove the wire and crush the stone.Endoscopic papillary large balloon dilation (eplbd) was difficult to perform because of the abrupt change in the position of the nipple.The wire was left in place, and an endoscopic nasobiliary drainage (enbd) tube was placed to complete the procedure.The patient was then given priority to treatment of cholangitis, and since the inflammation and hepatobiliary enzymes tended to decrease with decompression using the enbd tube, ercp was performed again on the 14th day of admission to the hospital to release the fitted stone.The physician attempted to push a basket forceps up into the common bile duct with the previous grasp of the stone, but this was also difficult, and the patient was referred to our department for surgical removal after it was determined that endoscopic removal would be difficult.On the 16th day of admission, the patient underwent bile duct incision lithotomy, lithotripsy, and cholecystectomy for common bile duct stones, gallbladder stones.Surgical findings: a 14 cm right subcostal incision was made, and the abdomen was opened.Although the patient had a postoperative transverse colon cancer, there was no obvious adhesion in the operative field.The hepatoduodenal mesentery was slightly thickened due to inflammation.A stone quarry tool and a stone were palpable in the lower common bile duct.The calot's triangle was also slightly inflamed, but dissection was relatively easy.After incision of the serosa of the gallbladder, the gallbladder and gallbladder bed were separated and the cholecystic artery was ligated and separated, and the hepatoduodenal mesentery was incised to expose the entire surface of the common bile duct.A support thread was placed with 4-opds at the level of the confluence of the bile ducts, and a l cm longitudinal incision was made in the bile duct.We attempted to grasp the lithotripter in the bile duct with forceps, but were only able to grasp the enbd tube, making it difficult to grasp the basket forceps.When the papillary region was gradually dilated with a biliary sonication bougie, the stone was removed from the stone and the stone fell into the duodenum, which was confirmed by the biliary endoscope.The stone was pulled up through the nose and removed through the mouth.No stone was found in the basket forceps, and it was thought that the stone fell during withdrawal.The enbd tube was also entangled in the basket forceps and was removed at the same time.When the intrahepatic bile duct was checked with a biliary speculum, a stone was found in the left intrahepatic bile duct, which was removed with a biliary spoon.The gallbladder was separated at the choledochal duct, and the choledochal duct was closed with continuous suture using 4-opds.The common bile duct was closed by placing a t-tube and suturing both ends of the incision with a single ligature using 5-opds.A 19fr break drain was placed in winslow to complete the surgery.Findings: enbd tube was entangled in the basket forceps.The gallbladder showed wall thickening and two gallstones of 5 mm in size were found inside.Postoperative course: the patient had a good postoperative course and was discharged on the 16th postoperative day.Two months after surgery, the patient was readmitted to the hospital and the t-tube was removed.Six months after surgery, there was no evidence of liver function abnormality.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.Since the literature described "litho crush 437", we selected "bml-v437qr-30" as a representative product.The exact model is not known.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be identified because the device was not returned for inspection.No abnormalities were detected in the dhr; therefore, it is inferred that the subject device did not have any abnormalities.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor.The pipe or the basket wire may break, and part of this instrument may remain in the body.Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor bml-110a-1.A lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place.This instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G., basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected.During lithotripsy, keep the portion from the coil sheath to the bml handle straight in line with the scope¿s biopsy valve, as much as possible.If not straight, the coil sheath may bend, calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.Do not rotate the bml handle knob abruptly.This instrument may break, and/or calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.¿ this olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15844620
• MDR Text Key: 304127368
• Report Number: 9614641-2022-00657
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218415
• UDI-Public: 04953170218415
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male