MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for NASAL SCISSORS 8211.221 manufactured by Richard Wolf Gmbh.
[40662403]
Actual device sent to manufacturer on 16mar2016. Investigation/evaluation currently in process. (b)(4) considers this report open, follow-up report to be submitted once investigation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40662404]
(b)(4). Facility reported one of the scissor tines broke off inside of patients nasal cavity during procedure. An x-ray and an ent surgeon was required to removed foreign object. In addition, patient was transferred to a higher level of care due to additional surgery and prolonged operating time.
Patient Sequence No: 1, Text Type: D, B5
[45372080]
Investigation report completed 05/13/2016. Cause of the break appears to be material fatigue due to normal wear and tear, device is over 15 years old. Labeling was reviewed and found to be adequate. Ie intended use, indications and field of use, preparation and cautions. Rw (b)(4) considers this matter closed. However, in the event additional information is received, rw (b)(4) will provide fda with follow-up information. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45372081]
Device was labeled such that it indicated it was last repaired in 1988. Hardness test was performed on device and passed current specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2016-00004 |
| MDR Report Key | 5502902 |
| Date Received | 2016-03-15 |
| Date of Report | 2018-06-01 |
| Date of Event | 2015-12-07 |
| Date Facility Aware | 2016-02-29 |
| Report Date | 2016-03-16 |
| Date Reported to FDA | 2016-03-16 |
| Date Reported to Mfgr | 2016-03-16 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2016-03-15 |
| 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 DAWN CLARK |
| Manufacturer Street | 353 CORPORTATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8003239653 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | REGISTRATION #9611102 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASAL SCISSORS |
| Generic Name | NASAL SCISSORS |
| Product Code | KBD |
| Date Received | 2016-03-15 |
| Returned To Mfg | 2016-03-16 |
| Model Number | 8211.221 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-03-15 |