MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for DYNJ58220 manufactured by Ethicon (johnson & Johnson).
[118550284]
It was reported that during a laparoscopic cholecystectomy, the ethicon ligaclip pack component misfired and fell into the surgical site. The surgeon was required to retrieve the misfired ethicon ligaclip from the surgical site via an unidentified method. The patient was under general anesthesia at the time of this incident. Reportedly, the incident added approximately fifteen (15) minutes to the overall procedure time. The patient did not require additional anesthesia and no further incident was reported. No impact to the patient, the patient's stability, or the patient's plan of care was reported. No serious injury or follow-up care reported. A sample was returned for evaluation. (b)(4) is the manufacturer of this device. (b)(4). Has been notified and will conduct an investigation and make the determination whether any corrective action is indicated. Due to the need for medical intervention to retrieve the misfired ethicon ligaclip from the surgical site, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[118550285]
It was reported that during a laparoscopic cholecystectomy, the ethicon ligaclip pack component misfired and fell into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00048 |
| MDR Report Key | 7822443 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-08-28 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | LIGACLIP IN DBD-LAP CHOLE PACK |
| Product Code | FDE |
| Date Received | 2018-08-28 |
| Returned To Mfg | 2018-08-20 |
| Catalog Number | DYNJ58220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON (JOHNSON & JOHNSON) |
| Manufacturer Address | ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK NJ 089011241 US 089011241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-28 |