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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY ZIMMON NEEDLE KNIFE PAPILLOTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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COOK ENDOSCOPY ZIMMON NEEDLE KNIFE PAPILLOTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number PTW-1E
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Esophagus (2399)
Event Type  Injury  
Manufacturer Narrative
Albers, d., dakkak, d., & schumacher, b.(2018).Su1136 flexible endoscopic myotomy in zenker diverticulum: no correlation between outcome and diverticulum size or pretreatment after complete septotomy.Gastrointestinal endoscopy, 87(6).Doi:10.1016/j.Gie.2018.04.1619.Date of event: between 04/2014 and 12/2016.Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30days of submission of this report with further information.
 
Event Description
During a mucomyotomy, the physician used a cook zimmon needle knife papillotome, as described in the below case report excerpt.".On day two (2) mucomyotomy under conscious sedation took place using a needle-knife (zimmon knife, cook medical, winston-salem, nc) with a diverticuloscope (cook medical, winston-salem, nc) or a standard transparent cap.The complete incision of the septum was intended in one session.On first postinterventional day water-soluble contrasted sophagogram excluded perforation and oral intake was started.Clinical success was defined as complete resolution of clinical symptoms and disappearance of diverticulum in esophagogram.Adverse events occurred.: microperforation (1) (subject of this report), all treated conservatively." it was not published in the article if a section of the device remained inside the patient¿s body.The patient experienced a micro perforation and was treated conservatively.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.
 
Manufacturer Narrative
Albers, d., dakkak, d., & schumacher, b.(2018).Su1136 flexible endoscopic myotomy in zenker diverticulum: no correlation between outcome and diverticulum size or pretreatment after complete septotomy.Gastrointestinal endoscopy, 87(6).Doi:10.1016/j.Gie.2018.04.1619 continued from section b3: between (b)(6) 2014 and (b)(6) 2016.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: the user indicated that mucomyotomy under conscious sedation was performed using the needle knife along with a diverticuloscope and a complete incision of the septum was intended in one session.This is outside the intended use of the device.The zimmon needle knife papillotome is intended to be used in the common bile duct.The instructions for use advise the user: "these devices are used for accessing the common bile duct when standard methods of cannulation have been exhausted." use of the device outside the intended use is the most likely cause for the reported observation.Prior to distribution, all zimmon needle knife papillotomes are subjected to a visual inspection and functional test to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that the device was used outside the intended use, 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.
 
Event Description
During a mucomyotomy, the physician used a cook zimmon needle knife papillotome, as described in the below case report excerpt.".On day two (2) mucomyotomy under conscious sedation took place using a needle-knife (zimmon knife, cook medical, winston-salem, nc) with a diverticuloscope (cook medical, winston-salem, nc) or a standard transparent cap.The complete incision of the septum was intended in one session.On first postinterventional day water-soluble contraste sophagogram excluded perforation and oral intake was started.Clinical success was defined as complete resolution of clinical symptoms and disappearance of diverticulum in esophagogram.Adverse events occurred.: microperforation (1) (subject of this report), all treated conservatively." it was not published in the article if a section of the device remained inside the patient¿s body.The patient experienced a micro perforation and was treated conservatively.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.
 
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Brand Name
ZIMMON NEEDLE KNIFE PAPILLOTOME
Type of Device
KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key8906887
MDR Text Key156329282
Report Number1037905-2019-00475
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K972674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPTW-1E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ENDOSCOPE -UNKNOWN MAKE AND MODEL
Patient Outcome(s) Other;
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