MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for STRAIGHT TROCAR SLEEVE 8919.333 manufactured by Richard Wolf Germany (rwgmbh).
[89173415]
Richard wolf medical instruments cooperation (rwmic) was informed that during a procedure a black plastic foreign object found during procedure. Foreign object was easily retrieved, back up device was readily available for use and procedure completed as scheduled. No injury to patient or staff reported. Date rwmic receive device: 02mar2017. Date facility purchased device: 26jul2017. Service dates: n/a. Device approximately 7 months old. Facility has been contacted, via phone and email, in an effort to gather additional/missing for medwatch report. No response received as of 09oct2017. No similar complaints have been reported on this device type in the last three years. Device has not been returned. Once rwmic receives device, it will be sent to manufacturer for investigation. Rwmic considers this report closed. If rwmic receives additional information regarding this incident, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2017-00027 |
| MDR Report Key | 6932439 |
| Date Received | 2017-10-09 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-06 |
| Date Facility Aware | 2017-09-18 |
| Report Date | 2017-11-07 |
| Date Reported to FDA | 2017-11-07 |
| Date Reported to Mfgr | 2017-11-07 |
| Date Added to Maude | 2017-10-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRAIGHT TROCAR SLEEVE |
| Generic Name | TROCAR SLEEVE |
| Product Code | FBQ |
| Date Received | 2017-10-09 |
| Returned To Mfg | 2017-11-03 |
| Model Number | 8919.333 |
| Catalog Number | 8919.333 |
| Lot Number | 1333148 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GERMANY (RWGMBH) |
| Manufacturer Address | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-09 |