MAUDE Adverse Event Report: COOK ENDOSCOPY UTS PRECURVED ULTRA TAPER SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22430
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k172665.The investigation is on going.A follow-up emdr will be provided with the completed investigation.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook uts pre-curved ultra taper sphincterotome.The cutting wire completely detached inside the patients body.The wire was unable to be found.This wire was unable to be found; it is unknown if it is still in the body, or may have came out during removal of the device and lost in the procedure room.It is unknown if the detached portion of the cutting wire is still in the 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.
Additional Manufacturer Narrative
Pma/510(k) # k172665.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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.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 degrees, 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 to: ¿upon removing device from package, uncoil and straighten sphincterotome." the user is then instructed to: ¿carefully remove precurved stylet wire from cannulating tip." the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to the sphincterotome and render it inoperable." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions caution the user: ¿contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope." 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 cutting wire breakage.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.Prior to distribution, all uts precurved ultra taper sphincterotomes are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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.Based on the information provided that this was used on a pediatric patient, 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.

• Brand Name: UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11748257
• Report Number: 1037905-2021-00173
• Device Sequence Number: 4226791
• Product Code: KNS
• UDI-Device Identifier: 00827002224308
• UDI-Public: (01)00827002224308(17)220606(10)W4223535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: G22430
• Device Catalogue Number: UTS-30M
• Device Lot Number: W4223535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METRO WIRE GUIDE, G26862; OLYMPUS ENDOSCOPE, MODEL UNKNOWN
• Patient Age: 6 MO