MAUDE Adverse Event Report: COOK ENDOSCOPY UNKNOWN

Catalog Number UNKNOWN

Device Problem Dull, Blunt (2407)

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895); No Known Impact Or Consequence To Patient (2692)

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.A review of the device history record could not be conducted because the 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.The size of tissue sample or biopsy to be excised can be controlled by how the user handles the forceps.If excessive pressure was applied during advancement into the tissue or during handle manipulation, this could have contributed to the reported observation.The instructions for use direct the user to advance the forceps into the tissue at the desired biopsy site.Then the user is instructed to close the forceps around the tissue while using slight pressure on the handle.The user is instructed to maintain gentle handle pressure to keep the cups closed and gently withdraw the forceps from the site.The instructions for use warns the user: "these single-use forceps should only be used to biopsy tissue where possible bleeding or hemorrhage will not present a danger for patients.Adequate plans for management of potential bleeding or hemorrhage and appropriate airway management should be in place." the instructions for use lists potential complications as: "those associated with gastrointestinal endoscopy include but are not limited to: perforation, bleeding or hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." prior to distribution, all captura disposable biopsy forceps are subjected to a visual inspection 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

The following information was provided from a third-party market research sponsor, during an in-depth interview of a blinded study: "during multiple endoscopic procedures, the physician used cook biopsy forceps with an unknown registered product number.Per the physician, the forceps are causing tearing and bleeding of the mucosa which is causing additional hemoclips to be placed as a result.The physician said this was "unique to the cook biopsy forceps." the following was received via audio file from the third-party research partner of the interview with the physician.Identities were not revealed in this recording.The relevant excerpts have been extracted below, as this interview was focused on hemoclips.Per the physician: the 4:10 of audio file: "our biopsy routinely- we have an issue with our biopsy forceps from cook.They bleed a lot.They rip off too much mucosa or something happens, so a lot of the time i am treating post biopsy bleeding caused by myself.And so i use hemoclip placement to do that [treat the bleeding] more often than anything else [sic- regarding a question on frequency of hemoclip usage]." the 10:47 of audio file: "[the use of hemoclips is] increased because of our cause with biopsy forceps.This is causing need for use of more hemoclips.We have tried to get new forceps, tried to do more superficial [biopsy] bites than deeper [biopsy bites], in order to try to avoid using hemoclips.I probably use these at least once per day." the 30:10 of audio file: "cook biopsy forcep are not good.".

• Brand Name: UNKNOWN
• Manufacturer (Section D): 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: 6591085
• MDR Text Key: 75964763
• Report Number: 1037905-2017-00314
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/03/2017
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention