MAUDE Adverse Event Report: COOK ENDOSCOPY THE WEB EXTRACTION BASKET; DISLODGER, STONE, BASKET, URETHRAL ,METAL

Catalog Number WEB-2X4

Device Problem Fracture (1260)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 05/15/2015

Event Type  Injury  

Event Description

During an endoscopy procedure, the physician used a cook web extraction basket.The basket broke inside of the pt.The pt was transferred to inpatient care for removal of the device portion.The pt complained of some discomfort and distress.A section of the device did not remain inside the pt's body.Pt was transferred to inpatient for removal of device portion.Pt complained of some discomfort and distress.

Manufacturer Narrative

Investigation eval: a prod eval was not performed in response to this report because the prod said to be involved was not provided to cook for eval.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: we could not conduct a complete investigation because the prod said to be involved was not returned for eval.A definitive cause for the reported observation could not be determined.The instructions for use for the web extraction basket include the following potential complication of including but not limited to impaction of object.Warning: surgical intervention may be required if impaction occurs.We advise the buckling of the drive cable can occur if the handle is moved back too far, and then pushed back into place.Breakage at this area may occur if extension and retraction of the basket is repeatedly attempted after buckling of the wires has occurred.For endoscopic advancement, the basket must be fully retracted into the outer sheath.Further retraction of the basket is not necessary.An ampullary opening inadequate to allow for the unimpeded passage of the stone and basket is listed in the web extraction basket instructions for use as a contraindication.The physician may choose to perform a sphincterotomy to widen the ampullary opening and allow passage of the basket and object(s) from the bile duct (ie bilary channel) to the small intestine.The instructions for use advise to withdraw the basket into channel until the foreign body is support against the endoscope tip, then withdraw the endoscope from pt.Maintain endoscope visualization to ensure continued entrapment of object.Caution: if difficulty is encountered when removing basket from duct, moderate force may be applied by pulling on handle to manually fracture stone.If passage is still restricted, surgical intervention may be necessary.Prior to distribution, all web extraction baskets are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that this lot met mfg requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the qual engineer rist assessment qa will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Manufacturer Narrative

A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: 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 instructions for use for the web extraction basket includes the following precautions: pulling on the sheath while advancing or retracting basket may damage device, rendering it inoperable.The instructions for use for the web extraction basket includes the following potential complication including but not limited to impaction of object.Warning: surgical intervention may be required if impaction occurs.We can advise that buckling of the drive cable can occur if the handle is moved back too far, and then pushed back into place.Breakage at this area may occur if extension and retraction of the basket is repeatedly attempted after buckling of the wires has occurred.For endoscopic advancement, the basket must be fully retracted into the outer sheath.Further retraction of the basket is not necessary.An ampullary opening inadequate to allow for the unimpeded passage of the stone and basket is listed in the web extraction basket instructions for use as a contraindication.The physician may choose to perform a sphincterotomy to widen the ampullary opening and allow passage of the basket and object(s) from the bile duct (i.E.Biliary channel) to the small intestine.Instructions for use advice to withdraw basket into channel until foreign body is supported against the endoscope tip, then withdraw endoscope from patient.Maintain endoscope visualization to ensure continued entrapment of object.Caution: if difficulty is encountered when removing basket from duct, moderate force may be applied by pulling on handle to manually fracture stone.If passage is still restricted, surgical intervention may be necessary.Prior to distribution, all web extraction baskets are subjected to a visual inspection to ensure device integrity.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: 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 instructions for use for the web extraction basket includes the following precautions: pulling on the sheath while advancing or retracting basket may damage device, rendering it inoperable.The instructions for use for the web extraction basket includes the following potential complication including but not limited to impaction of object.Warning: surgical intervention may be required if impaction occurs.We can advise that buckling of the drive cable can occur if the handle is moved back too far, and then pushed back into place.Breakage at this area may occur if extension and retraction of the basket is repeatedly attempted after buckling of the wires has occurred.For endoscopic advancement, the basket must be fully retracted into the outer sheath.Further retraction of the basket is not necessary.An ampullary opening inadequate to allow for the unimpeded passage of the stone and basket is listed in the web extraction basket instructions for use as a contraindication.The physician may choose to perform a sphincterotomy to widen the ampullary opening and allow passage of the basket and object(s) from the bile duct (i.E.Biliary channel) to the small intestine.Instructions for use advice to withdraw basket into channel until foreign body is supported against the endoscope tip, then withdraw endoscope from patient.Maintain endoscope visualization to ensure continued entrapment of object.Caution: if difficulty is encountered when removing basket from duct, moderate force may be applied by pulling on handle to manually fracture stone.If passage is still restricted, surgical intervention may be necessary.Prior to distribution, all web extraction baskets are subjected to a visual inspection to ensure device integrity.

• Brand Name: THE WEB EXTRACTION BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETHRAL ,METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4860086
• MDR Text Key: 17583310
• Report Number: 1037905-2015-00244
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WEB-2X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• 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