MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-24 for INSTINCT ENDOSCOPIC HEMOCLIP G18343 INSC-7-230-S manufactured by Cook Endoscopy.
[146097928]
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 instructions for use state: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope or colonoscope. Caution: holding handle spool during advancement may prematurely deploy clip. " prior to distribution, all instinct endoscopic hemoclips are subjected to a visual inspection and functional testing 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.
Patient Sequence No: 1, Text Type: N, H10
[146097929]
During a colonoscopy, the physician used a cook instinct endoscopic hemoclip. The clip did not open when it was in position in the colon and was not detached. When they removed the device from the endoscope, it was detached [clip deploys in endoscope]. A section of the device did not remain inside the patient? S body. It is unknown how the clip was removed from the endoscope channel. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2019-00283 |
| MDR Report Key | 8640968 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2019-05-24 |
| 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 | INSTINCT ENDOSCOPIC HEMOCLIP |
| Generic Name | PKL, LIGATOR, HEMORRHOIDAL |
| Product Code | PKL |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-05-28 |
| Model Number | G18343 |
| Catalog Number | INSC-7-230-S |
| Lot Number | W4171811 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-24 |