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

Catalog Number DASH-ACRO-35-450

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k172665.Initial reporter occupation: unknown.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report, because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.A photo of the lot number was not provided.Our evaluation of the photos provided by the customer of the product said to be involved confirmed the report.The photos show damaged coating near the distal tip of the device, and the core wire is exposed.Without clearer markings visible at the distal end, it is difficult to estimate the exact location of the damage.It cannot be determined if any sections of the coating are missing based on the photos.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the photos provided by the user show damaged coating near the distal tip of the device.We could not conduct a complete investigation however because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all d.A.S.H.® pre-loaded with acrobat wire guides are subjected to a visual inspection and functional testing to ensure device integrity.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a d.A.S.H.® pre-loaded with acrobat wire guide.The pre-loaded sphincterotome was inserted into the access channel and the wire guide was cannulated.The physician realized immediately that the wire was split.The sphincterotome was retrieved and a new sphincterotome was used to proceed.Unfortunately the broken set was thrown away.On 22-apr-2021 photos of the device were received depicting coating damage in the tip range [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: D.A.S.H. 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: kaylin davis ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 11826651
• MDR Text Key: 251769953
• Report Number: 1037905-2021-00199
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DASH-ACRO-35-450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• 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