MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-25 for UNKNOWN manufactured by Cook Endoscopy.
[75964763]
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. 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 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 warns the user: "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 disposable biopsy forceps 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
[75964844]
The following information was provided from a third-party market research sponsor, during an in-depth interview of a blinded study: "during multiple endoscopic procedures, the physician used cook biopsy forceps with an unknown registered product number. Per the physician, the forceps are causing tearing and bleeding of the mucosa which is causing additional hemoclips to be placed as a result. The physician said this was "unique to the cook biopsy forceps. " the following was received via audio file from the third-party research partner of the interview with the physician. Identities were not revealed in this recording. The relevant excerpts have been extracted below, as this interview was focused on hemoclips. Per the physician: the 4:10 of audio file: "our biopsy routinely- we have an issue with our biopsy forceps from cook. They bleed a lot. They rip off too much mucosa or something happens, so a lot of the time i am treating post biopsy bleeding caused by myself. And so i use hemoclip placement to do that [treat the bleeding] more often than anything else [sic- regarding a question on frequency of hemoclip usage]. " the 10:47 of audio file: "[the use of hemoclips is] increased because of our cause with biopsy forceps. This is causing need for use of more hemoclips. We have tried to get new forceps, tried to do more superficial [biopsy] bites than deeper [biopsy bites], in order to try to avoid using hemoclips. I probably use these at least once per day. " the 30:10 of audio file: "cook biopsy forcep are not good. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2017-00314 |
| MDR Report Key | 6591085 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-25 |
| Date Mfgr Received | 2017-05-03 |
| Date Added to Maude | 2017-05-25 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | FBK |
| Date Received | 2017-05-25 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-05-25 |