MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for RHOTON SELLA PUNCH 1MM WIDE UPCUT 45DEG NL3785-164 manufactured by Carefusion, Inc.
[109371391]
(b)(4) on 10may2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[109371392]
Medwatch report states: #1 kerrison instrument used during posterior cervical instrumentation. Tip of kerrison noted to have broken off during procedure. Radiographic confirmation obtained that tip of instrument was not retained in patient. Suction filter was radiographed and tip found to be seated in filter of the suction machine. Cpd (central processing department) manager notified. Broken instrument isolated w/suction filter and given to central processing department who dismantled suction filter and sifted piece out. What was the original intended procedure? Decompression and fusion posterior cervical spine one lever- c2-c7 fusion posterior cervical spine three or more levels-laminectomy cervical spine with decompression and instrumentation two levels. Patient was not harmed in this incident. On 11may2018 additional information: is it normal procedure to take an x-ray of the patient or was this only done to verify the location of the broken tip of the instrument? It is standard procedure to have c-arm (x-ray) in the room during this procedure. X-ray is used to confirm placement of instrumentation during and immediately prior to patient leaving the or. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00009 |
| MDR Report Key | 7530173 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-05-04 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2018-05-21 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RHOTON SELLA PUNCH 1MM WIDE UPCUT 45DEG |
| Generic Name | KERRISON RONGEURS |
| Product Code | HAE |
| Date Received | 2018-05-21 |
| Catalog Number | NL3785-164 |
| Lot Number | XMEA 03 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-21 |