MAUDE Adverse Event Report: COOK ENDOSCOPY UNKNOWN

Catalog Number UNKNOWN

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/20/2014

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be sent following the completion of the investigation.Kim, c.W., chang, j.H., kim, t.H., & han, s.W.(2014).Rescue balloon dilation of the ampulla for retrieving an impacted biliary extraction basket.Journal of digestive diseases, 15(11), 636¿639.Https://doi.Org/10.1111/1751-2980.12181.

Event Description

Cook endoscopy was notified of this event via a clinical literature article.This article was published in 2014.Please see below for relevant excerpts of this article.¿a (b)(6)-year-old woman was admitted to the emergency center (b)(6) hospital due to jaundice and having experienced a mild fever for 3 days.Magnetic resonance cholangiopancreatography (mrcp) demonstrated two large stones with a diameter of 15 mm and 9 mm, respectively, in the distal common bile duct (cbd) (fig.1a).Ercp was performed to remove cbd stones using the duodenoscope (jf 240; olympus, (b)(4)).After deep cannulation into the cbd, endoscopic sphincterotomy was performed with a papillotome.A dormia basket (wilson-cook medical, (b)(4), usa) was introduced into the cbd to remove the stones.After capturing the stones with the basket, we tried to retrieve the basket containing the stone from the cbd.However, the basket and stones were impacted in the distal cbd near the ampulla.Subsequently, a mechanical lithotripsy was performed.However, the basket wires were fractured at the patient¿s oral side, and the fractured basket remained in the cbd.Cre¿ controlled radial expansion balloon dilator (12 mm in diameter; boston scientific, (b)(4), usa) was introduced into the cbd alongside the basket wire.The balloon was positioned across the ampulla and inflated gradually.The balloon was inflated besides the basket wire in the cbd to 12 mm in diameter.After the balloon dilation of the ampulla, the fractured basket with entrapped stones was successfully retrieved from the cbd.The symptoms and laboratory findings of the patient were improved thereafter.Post-ercp complications such as pancreatitis or bleeding did not occur.¿ a section of the device remained temporarily inside the patient¿s body, but was successfully removed.Based on the article, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Kim, c.W., chang, j.H., kim, t.H., & han, s.W.(2014).Rescue balloon dilation of the ampulla for retrieving an impacted biliary extraction basket.Journal of digestive diseases, 15(11), 636¿639.Https://doi.Org/10.1111/1751-2980.12181.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.The pictures in the article show the retrieval of a fractured basket by rescue balloon dilation following mechanical lithotripsy.The pictures confirm the reported occurrence.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The lxb instructions for use includes the following, "if a stone cannot be removed endoscopically with this basket, a compatible inflation/lithotriptor device and/or the conquest ttc lithotripter cable with soehendra lithotriptor handle are needed to mechanically crush stone and aid in removal.Basket wires may fragment and/or stone impaction may occur during lithotripsy, requiring surgical intervention." the msb instructions for use includes the following, "surgical intervention may be required if stone impaction and/or basket fragmentation occurs.If a stone cannot be removed endoscopically with this basket, the soehendra lithotriptor may be used with select memory soft wire baskets (see package label) to mechanically crush stone and aid in removal.Due to mechanical pressure generated with soehendra lithotriptor, basket fragmentation and/or stone impaction in common bile duct may occur and require surgical intervention.Risk of basket fragmentation or stone impaction must be weighed against potential benefit of using lithotriptor." the web instructions for use includes the following, "surgical intervention may be required if stone impaction and/or basket fragmentation occurs." prior to distribution, all extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12082818
• MDR Text Key: 259150251
• Report Number: 1037905-2021-00280
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, OLYMPUS JF 240; UNKNOWN LITHOTRIPTER
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR