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); Tissue Damage (2104)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.(b)(4).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 device history record for the lot number said to be involved was reviewed.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 warn: "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 pro disposable biopsy forceps are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot 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 a colonoscopy, the physician used a cook captura pro biopsy forceps with spike.The physician commented to the cook sales district manager that it [the forceps] was taking too big of a bite.Because the bite was so big, it was causing a hemotaoma in the mucosa.The physician will be trying the 2.2 mm cup size as it is a smaller cup size.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: 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: 8241472
• MDR Text Key: 133283977
• Report Number: 1037905-2019-00011
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476974
• UDI-Public: (01)00827002476974(17)210821(10)W4110645
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: BF-2.4SL-160SP-40
• Device Lot Number: W4110645
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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