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-160SP-40

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Hemostasis (1895)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.(b)(4).Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During an unspecified number of procedures, the physician used multiple cook captura pro biopsy forceps with spike.Up until a month ago the physician was using another manufacturer's forceps.Now the physician has been using the cook large biopsy forceps.The physician had commented that he had never noticed this issue before with the other manufacturer's forceps.The cook large biopsy forceps are biting bigger and deeper, resulting in more bleeding and "hemotomas".A section of the device did not remain inside the patient¿s body.In some cases, the patient required a hemoclip to close up the defect caused by the forceps.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Occupation: non-healthcare professional.Device code: 3191-appropriate term/code was not available was used for this event.The preferred term for this event is: product does not function as anticipated.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 possible lot numbers of the product said to be involved were used to review the device history records.A discrepancy or anomaly was not observed with the product that was released for distribution.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 warning state: "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 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 pro disposable biopsy forceps are subjected to a visual inspection to ensure device integrity.A review of the device history record for the possible lot numbers confirmed that the lots said to be involved met all manufacturing requirements prior to shipment.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 unspecified number of procedures, the physician used multiple cook captura pro biopsy forceps with spike.Up until a month ago the physician was using another manufacturer's forceps.Now the physician has been using the cook large biopsy forceps.The physician had commented that he had never noticed this issue before with the other manufacturer's forceps.The cook large biopsy forceps are biting bigger and deeper, resulting in more bleeding and hemotomas.A section of the device did not remain inside the patient¿s body.In some cases, the patient required a hemoclip to close up the defect caused by the forceps.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.

• 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
• MDR Report Key: 8241467
• MDR Text Key: 132863555
• Report Number: 1037905-2019-00012
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BF-2.4SL-160SP-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GIF-HQ190 ENDOSCOPE; OLYMPUS GIF-HQ190 ENDOSCOPE
• Patient Outcome(s): Required Intervention