MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SOEHENDRA LITHOTRIPSY CABLE; LQC, LITHOTRIPTER, BILIARY MECHANICAL

Catalog Number UNKNOWN

Device Problems Accessory Incompatible (1004); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

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 photos in the article show a cholangiogram that show use of an olympus extraction basket to fragment multiple large stones in the common bile duct.The pictures are inconclusive for the reported occurrence.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 photos in the report show an olympus lithotriptor basket was used.The instructions for use (ifu) warns, "only select cook biliary soft wire baskets are recommended for use with this device." use with an incompatible basket is the likely root cause of the device failure.Prior to distribution, all soehendra lithotriptor handles are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: 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.Zargar, s.A., shah, a.H., javid, g., khan, b.A., yattoo, g.N., shah, a.H., gulzar, g.M., sodhi, j.S., & khan, m.A.(2012).Endoscopic mechanical lithotripsy of large difficult bile duct stones: success, complications and predictors of failure.Journal of digestive endoscopy, 3(4), 42-43.

Event Description

Cook endoscopy was notified of this event via a clinical literature article.This article was published in 2012 and involved a cook soehendra lithotripsy cable.Please see below for relevant excerpts of this article.¿the aim of this retrospective study is to evaluate the usefulness, safety and feasibility of mechanical lithotripsy ¿ the cheapest of all modalities ¿ for extraction of large and/or difficult stones which defied removal by standard techniques.During a 4-year period mechanical lithotripsy using sochendra and bml olympus lithotriptor was performed in 105 patients with bile duct stones that could not be removed using standard endoscopic techniques.There were 56 males and 49 females with a mean age of 62 ± 22.4 years (range, 22 - 102 years).Stone size ranged from 8-35 mm (mean, 15 ± 7 mm) and stone number ranged 1-8; 89% patients of them had 1-3 stones.We conclude that mechanical lithotripsy is a safe, simple and effective approach for removal of bile duct stones in 81% that defy conventional endoscopic approaches.The complications are minimal.Stone size of 28 mm or more (p < 0.01) and impacted stone (p <0.001) were predictors of failure of lithotripsy for a difficult bile duct stone; such patients should undergo early for surgery or other non-surgical procedures to avoid wasting time and resources¿.Technical problems of mechanical lithotripsy of basket fracture were observed¿ one had fractured basket with both sochendra and olympus lithotriptor.The latter patient underwent surgery [subject of this report].".

• Brand Name: SOEHENDRA LITHOTRIPSY CABLE
• Type of Device: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12309028
• MDR Text Key: 266089490
• Report Number: 1037905-2021-00372
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE- UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention