MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Catalog Number BF-2.4SL-230SP-40

Device Problem Dull, Blunt (2407)

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895)

Event Type  Injury  

Manufacturer Narrative

Initial reporter 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 customer provided two (2) photos of the bleeding site after biopsy was taken.Based on the photos provided by the user, the complaint is considered 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 (ifu) direct the user to, ¿advance forceps to biopsy or retrieval site, then open cups and advance into tissue to be biopsied or object to be retrieved.Using slight pressure on handle, close forceps around tissue or object.Maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site.¿ the ifu warns, "these single-use biopsy 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 ifu 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 pro biopsy forceps with spike 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

During colon biopsy procedures, the physician has used at least two (2) cook captura pro¿ biopsy forceps with spike and indicated that the forceps cause too much bleeding, resulting in using more hemoclips [a general, recurring complaint].The cook [district sales manager] has [provided] two (2) photos as an example (post-biopsy on a patient that is on blood thinners).The photos depict bleeding tissue.No sections of the devices remained inside the patients' bodies.The patients required additional hemoclips due to these occurrences.According to the initial reporter, the patients did not experience any adverse effects due to these occurrences.

• Brand Name: CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• 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: 8453014
• MDR Text Key: 139886577
• Report Number: 1037905-2019-00153
• Device Sequence Number: 1
• Product Code: PTS
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BF-2.4SL-230SP-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• 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 PCF-H190 COLONOSCOPE
• Patient Outcome(s): Required Intervention