MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number G34693

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: two (2) devices returned for evaluation.It is unknown which device penetrated the mucosa [subject of report] therefore both devices are included in the evaluation.Included with the returned devices was a photo that shows one of the devices in vivo exiting the endoscope.It appears the cutting wire has broken and is situated within the tissue.Due to a limited portion of the device being visible, the device part number cannot be verified in the photos showing it used in vivo.For device one (1), our laboratory evaluation of the product said to be involved confirmed the report.The cutting wire has broken near the proximal end.Due to the break in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.The cutting wire exhibits slight evidence of a cautery application (blackening of the cutting wire was noted).No section of the cutting wire is missing.An unknown brown substance was observed in the pouch and on the distal end of the device.The catheter was bent at approximately 49.5cm from the distal end.Liquid was also observed in the catheter.For device two (2) our laboratory evaluation of the product said to be involved confirmed the report.The cutting wire has broken near the proximal end.Due to the break in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.The cutting wire exhibits slight evidence of a cautery application (blackening of the cutting wire was noted).No section of the cutting wire is missing.Liquid was also observed in the catheter.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.If the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and additional pressure is applied, this could contribute to the reported observation.The instructions for use caution the user: ¿elevator should remain open/down when advancing or retracting sphincterotome.¿ this activity will aid in device preservation.Cutting wire breakage can occur if the distal end if formed manually.The instructions for use states the following: "note: do not apply manual pressure to tip or cutting wire of sphincterotome in an attempt to influence orientation, as this may result in damage to the device." a broken cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user; "do not over flex or bow tip beyond 90°, as this may damage or cause cutting wire to break." cutting wire breakage can occur if the handle is manipulated with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user: ¿upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip.¿ the instructions for use contains the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." prior to distribution, all fusion® pre-loaded with acrobat wire guides are subjected to a visual inspection to ensure device integrity.The visual inspection ensures the product is free of kinks.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook fusion® pre-loaded with acrobat wire guides.The cutting wire broke during the procedure.This event was not reportable.On 27-aug-2020 the devices were returned with a procedural photo.The photo shows one (1) of the devices where the cutting wire penetrated the mucosa in an intended area [subject of report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 10559348
• MDR Text Key: 207738882
• Report Number: 1037905-2020-00393
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002346939
• UDI-Public: (01)10827002346939(17)211126(10)W4147113
• Combination Product (y/n): N
• Reporter Country Code: AE
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: G34693
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Device Lot Number: W4147113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• 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
• Treatment: ENDOSCOPE, MAKE AND MODEL UNKNOWN
• Patient Weight: 70