MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-26 for CAPTURA PRO? BIOPSY FORCEPS WITH SPIKE BF-2.4SL-230SP-40 manufactured by Cook Endoscopy.
[139886577]
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.
Patient Sequence No: 1, Text Type: N, H10
[139886578]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2019-00153 |
| MDR Report Key | 8453014 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-01 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURA PRO? BIOPSY FORCEPS WITH SPIKE |
| Generic Name | PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT |
| Product Code | PTS |
| Date Received | 2019-03-26 |
| Catalog Number | BF-2.4SL-230SP-40 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-26 |