MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-23 for NOVAPASS STRAIGHT SUTURE PASSER N/A C-PAS-180-16.0 manufactured by Cook Inc.
[65468817]
(b)(4). Class i device. The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the internal investigation.
Patient Sequence No: 1, Text Type: N, H10
[65468818]
The physician / device user reported slashing her right index finger with the novapass straight suture passer during a procedure on an unspecified date. The physician / device user was seen in the emergency room; sutures were offered to close the wound. The physician declined the offer. The reporting physician / user was performing an unspecified procedure on a patient that was described as having a thick abdominal wall; the patient tested negative for blood borne pathogens. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[73930445]
Investigation - evaluation: a review of the complaint history, instructions for use (ifu), specifications and quality control was conducted during the investigation. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly a review of the device history record could not be conducted. The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "do not use the suture passer in a procedure where the position of the needle tip cannot be clearly identified. Novapass suture passers have needle-point tips that can cause injury to internal tissue and/or any personnel who may come in contact with the device. The needle-point tip should be kept protected with the protective cap whenever the device is not in use. " based on the information provided, no product returned and the results of our investigation, user technique / user error contributed to the event. We will continue to monitor for similar complaints. Measures are being conducted to address this failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-00085 |
| MDR Report Key | 6269422 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-23 |
| Date of Report | 2017-04-17 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-01-23 |
| 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 | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVAPASS STRAIGHT SUTURE PASSER |
| Generic Name | GEJ CARRIER, LIGATURE |
| Product Code | GEJ |
| Date Received | 2017-01-23 |
| Model Number | N/A |
| Catalog Number | C-PAS-180-16.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-23 |