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| Catalog Number SLH-1 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Ryozawa, s., iwano, h., taba, k., senyo, m.And sakaida, i.(2010), successful retrieval of an impacted mechanical lithotripsy basket: a case report.Digestive endoscopy, 22: s111-s113.Doi:10.1111/j.1443-1661.2010.00963.X.Date of event: 2010.Concomitant medical products: conquest ttc lithotriptor cable with adapter (ttcl-1).Zeon medical xemex crusher catheter (lbgt-7420s).Device not returned.Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with further information.
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Event Description
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During a stone extraction procedure as described in the below case report, the physician used a cook soehendra lithotriptor handle."endoscopic retrograde cholangiopancreatography (ercp) is highly effective for the treatment of choledocholithiasis.On rare occasions, stone extraction baskets can become impacted in the common bile duct if they capture a stone that is too large to remove via traction and if the basket and stone complex cannot be separated to allow just the basket to be removed from the patient.A variety of endoscopic, radiological, and surgical techniques have been used to remedy this situation.With the advent of mechanical lithotripters, stones captured within an impacted basket are either crushed or the wires of the basket broken to release the trapped basket.We present here a novel method for retrieval of an entrapped mechanical basket where the central wire of the basket fractured at the handle portion during an attempt to use the soehendra through-the-scope (tts) lithotripter.A (b)(6) year-old woman presented initially to another local hospital with right hypochondrial pain and fever.Ultrasound imaging showed a dilated common bile duct (cbd) containing two large stones.The patient was referred to our hospital for further management.Ercp showed two large cbd stones measuring 2.5 cm in diameter.After endoscopic sphincterotomy, a basket mechanical lithotripter was inserted to engage the stone.The stone was extremely hard to crush; hence, the basket with the entrapped stone was impacted within the mid-cbd.The outer sheath covering the basket had been removed leaving the bare wires exposed.We then attempted to use another mechanical lithotripter (conquest ttc lithotripter cable [concomitant product] and soehendra lithotripter handle (subject of this report); cook endoscopy, (b)(4), usa) to either crush the stone or break the fibers of the basket.However, on cranking the lithotripter [handle], the central wire of the basket fractured at the handle portion [not at portion in patient] (subject of this report).The duodenoscope was reintroduced and rat-tooth forceps were inserted through the accessory channel.Care was taken to ensure that few wires of the impacted [intact] basket were grasped with the rat-tooth forceps.This was achieved and then the trapped [intact] basket was disengaged from the stone.The patient underwent choledocholithotomy [surgical removal of pre-existing stone, not removal of device portion] and was discharged uneventfully.At endoscopic stone removal it is essential to have suitable accessories available, particularly the extra-endoscopic mechanical lithotripter or the newly developed tts [through the endoscope] lithotripters, in the event that entrapment of a basket occurs.In our patient we first attempted to use the soehendra tts lithotripter, but the central wire of the basket fractured at the handle portion, which made further attempts with this type of device impossible.We describe here a simple but novel method that may be attempted by others facing a similar predicament.Grasping a few wires of the impacted [intact] basket with rat-tooth forceps allowed the wires of the basket to slip away from the stone.The simplicity of this maneuver makes it a worthwhile first-line salvage technique before subjecting the patient to more complicated and invasive procedures." a section of the device did not remain inside the patient¿s body.The trapped non-cook basket was removed from the stone with rat-tooth forceps.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.
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Manufacturer Narrative
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Ryozawa, s., iwano, h., taba, k., senyo, m.And sakaida, i.(2010), successful retrieval of an impacted mechanical lithotripsy basket: a case report.Digestive endoscopy, 22: s111-s113.Doi:10.1111/j.1443-1661.2010.00963.X.Continued from section b3 date of event: 2010.Continued from section d11: conquest ttc lithotriptor cable with adapter (ttcl-1).Zeon medical xemex crusher catheter (lbgt-7420s).(b)(4).Investigation evaluation: a product evaluation was performed only by the pictures provided in the article, because the product said to be involved was not provided to cook for evaluation.We cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements describing the event.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the device was used with an incompatible basket (use error).The article indicates that another manufacturer's incompatible extraction basket was inserted to engage the stone.The instructions for use (ifu) warns, "due to mechanical pressure generated with this device, basket fragmentation in the common bile duct is a possibility that may require surgical intervention.Only specified wilson-cook soft lithotripsy-compatible baskets are recommended for use with this device.Do not remove the 7 french sheath from basket wire.Doing so may result in basket fragmentation and consequentially require surgical intervention.Due to the varying compositions of biliary stones, stone fracture may not be possible.If stone cannot be fractured, continued rotation of the handle may cause the basket wire to break, requiring surgical intervention." the ifu instructs, "slow, constant pressure is often the most effective method of fracturing a stone.Sudden release of pressure may indicate the fracture of the stone, fracture of the basket, or loss of the stone from the basket." prior to distribution, all soehendra lithotriptor handles are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that the device was used with incompatible accessories, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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Event Description
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During a stone extraction procedure as described in the below case report, the physician used a cook soehendra lithotriptor handle."endoscopic retrograde cholangiopancreatography (ercp) is highly effective for the treatment of choledocholithiasis.On rare occasions, stone extraction baskets can become impacted in the common bile duct if they capture a stone that is too large to remove via traction and if the basket and stone complex cannot be separated to allow just the basket to be removed from the patient.A variety of endoscopic, radiological, and surgical techniques have been used to remedy this situation.With the advent of mechanical lithotripters, stones captured within an impacted basket are either crushed or the wires of the basket broken to release the trapped basket.We present here a novel method for retrieval of an entrapped mechanical basket where the central wire of the basket fractured at the handle portion during an attempt to use the soehendra through-the-scope (tts) lithotripter.A 69-year-old woman presented initially to another local hospital with right hypochondrial pain and fever.Ultrasound imaging showed a dilated common bile duct (cbd) containing two large stones.The patient was referred to our hospital for further management.Ercp showed two large cbd stones measuring 2.5 cm in diameter.After endoscopic sphincterotomy, a basket mechanical lithotripter was inserted to engage the stone.The stone was extremely hard to crush; hence, the basket with the entrapped stone was impacted within the mid-cbd.The outer sheath covering the basket had been removed leaving the bare wires exposed.We then attempted to use another mechanical lithotripter (conquest ttc lithotripter cable [concomitant product] and soehendra lithotripter handle (subject of this report); cook endoscopy, winston-salem, nc, usa) to either crush the stone or break the fibers of the basket.However, on cranking the lithotripter [handle], the central wire of the basket fractured at the handle portion [not at portion in patient] (subject of this report).The duodenoscope was reintroduced and rat-tooth forceps were inserted through the accessory channel.Care was taken to ensure that few wires of the impacted [intact] basket were grasped with the rat-tooth forceps.This was achieved and then the trapped [intact] basket was disengaged from the stone.The patient underwent choledocholithotomy [surgical removal of pre-existing stone, not removal of device portion] and was discharged uneventfully.At endoscopic stone removal it is essential to have suitable accessories available, particularly the extra-endoscopic mechanical lithotripter or the newly developed tts [through the endoscope] lithotripters, in the event that entrapment of a basket occurs.In our patient we first attempted to use the soehendra tts lithotripter, but the central wire of the basket fractured at the handle portion, which made further attempts with this type of device impossible.We describe here a simple but novel method that may be attempted by others facing a similar predicament.Grasping a few wires of the impacted [intact] basket with rat-tooth forceps allowed the wires of the basket to slip away from the stone.The simplicity of this maneuver makes it a worthwhile first-line salvage technique before subjecting the patient to more complicated and invasive procedures." a section of the device did not remain inside the patient¿s body.The trapped non-cook basket was removed from the stone with rat-tooth forceps.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.
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Search Alerts/Recalls
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