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

Model Number G50697

Device Problem Dull, Blunt (2407)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Information regarding occupation: non-healthcare professional.Evaluation conclusion: a product evaluation was not performed because the product said to be involved was not provided to cook for evaluation.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.Evaluation investigation: 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 objected 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 are subjected to a visual inspection and functional test to ensure proper workability.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 an esophagogastroduodenoscopy (egd) procedure in which qty.1 of the captura pro biopsy forceps with spike, g50697, was used.When the biopsy piece of mucosa was extracted it caused approximately a 3-4 cm laceration.The laceration bled very little bit but required no intervention as it took care of itself.But the physician did intervene and placed a hemoclip just in case.The physician mentioned that the patient was in declined health which may have compromised the tissue integrity.The following was received on 03 october 2019: the customer stated that the bleed took care of it¿s self.But he did place an instinct clip just in case, to reduce risk re-bleed.A section of the device did not remain inside the patient¿s body.The patient required a clip to be placed 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: 9153826
• MDR Text Key: 161201201
• Report Number: 1037905-2019-00577
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002506978
• UDI-Public: (01)00827002506978(17)220624(10)W4229969
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: G50697
• Device Catalogue Number: BF-2.4SL-230SP-40
• Device Lot Number: W4229969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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
• Patient Outcome(s): Required Intervention