MAUDE Adverse Event Report: COOK ENDOSCOPY UNKNOWN; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

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 could not be reviewed because a lot number was not provided.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 product experiences limited movement of the needle knife during electrocautery application.The instructions for use for the potential reference part number (rpn) state: (needle knifes having rpns hpc-2 and hpc-3): "caution: it is essential to move needle knife while applying current." (needle knife with rpn fs-precut): "caution: it is essential to move cutting wire while applying current.Maintaining cutting wire in one position may cause excessive focal coagulation, charring of tissue and/or damage to cutting wire." (needle knifes with rpns ptw-1 and ptw-1e): "it is essential to move the needle knife while applying current." maintaining the needle knife in one position can result in breakage of the needle knife.This is the most likely cause of needle breakage.(needle knifes having rpns hpc-2 and hpc-3): "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." "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 with rpn fs-precut): "before using this papillotome, follow the recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper placement and utilization of the patient return electrode.Ensure a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." "when applying current, 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." (needle knifes with rpns ptw-1 and ptw-1e): "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 that proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." "when applying current, ensure the cutting wire is completely out of endoscope.Contact of cutting wire with the endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to endoscope." prior to distribution, all needle knives are subjected to a visual inspection and functional test to ensure device integrity.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 a cook needle knife (unknown reference part number and lot number).The needle knife broke off inside the patient.They were able to retrieve the broken piece.A section of the device did not remain inside the patient¿s body.The detached portion of the needle knife was retrieved due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• 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: 8408048
• MDR Text Key: 138387703
• Report Number: 1037905-2019-00123
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: 02/14/2019
• 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
• Treatment: OLYMPUS ERCP 180 ENDOSCOPE
• Patient Outcome(s): Required Intervention