MAUDE Adverse Event Report: COOK ENDOSCOPY HUIBREGTSE NEEDLE KNIFE PAPILLOTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22037
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: erbe electrosurgical generator.Occupation: non-healthcare professional.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.Needle knife breakage near the distal end can occur if the device is used with excessive cautery settings.The instructions for use direct the user: "before using this device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." needle knife breakage near the distal end can occur if the needle makes contact with the distal end of the endoscope during a cautery application.The instructions for use caution the user: "when applying current, ensure needle knife is completely out of endoscope.Contact of needle knife with endoscope may cause grounding, which can result in patient injury, operator injury, a broken needle knife, and/or damage to endoscope." needle knife breakage near the distal end can also occur if the product experiences limited movement of the needle knife during electrocautery application.The instructions for use state: "caution: it is essential to move needle knife while applying current." maintaining the needle knife in one position can result in breakage of the needle knife.Prior to distribution, all huibregtse needle knife papillotomes are subjected to a visual inspection and functional test 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: 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook huibregtse needle knife papillotome.The device fell apart and is in pieces.All the pieces were retrieved.The following additional information was received on 05/29/2019: the tip of the device fell off into patient and was retrieved with forceps.A section of the device did not remain inside the patient's body.The detached portion of the device was retrieved with forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
• 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: 8676210
• Report Number: 1037905-2019-00308
• Device Sequence Number: 2372164
• Product Code: KNS
• UDI-Device Identifier: 00827002220379
• UDI-Public: (01)00827002220379(17)210904(10)W4112697
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K972674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: G22037
• Device Catalogue Number: HPC-2
• Device Lot Number: W4112697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 90