MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-02 for GOLDMANN TONOMETER PRISM NONE 1902615 manufactured by Haag-streit Ag.
[44154394]
We received a complaint about tonometer prisms from an o. D. In (b)(6) on 28th december 2015. As there were three corneal burns and prisms bloated as documented and conveyed to haag-streit (b)(4). Haag-streit (b)(4) product manager, (b)(4) contacted (b)(4) to discuss the concerns above to acquire further information about the disinfection process they are utilizing and the bloating of the tonometer prisms. Currently per haag-streit (b)(4) the problem appears to be abnormal use of the medical device per the instructions for use provided by haag streit (b)(4). The current situation is the hospital sps personnel have disinfected all of the tonometer prisms due to concerns mentioned above. It appears the instructions for use is not being followed as written by haag-streit (b)(4). Secondly, the end user recently hired 3 new technicians. Additional information is needed as well as returning the affected medical devices (tonometers prisms) from (b)(6) medical center or the (b)(6) to haag-streit (b)(4) for further investigation into these problems. Important information concerning this medwatch: haag-streit usa was initially unsuccessful in setting up our webtrader account due to configuration issues. This has taken several months to correct. We contracted an it group (clearlogic) to assist us to complete the install. We were in constant contact with several people from the esg help desk and the cdrh in attempts to correct this concern through the entire configuration process. Haag-streit usa received approval for emdr production test submissions as of 04/25/2016. If you have any questions or concerns regarding this medwatch (emdr) please contact us and we will provide any further information to assist the fda. Respectfully, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44154395]
We have recently been forced to have our hospital's sterile processing service (sps) disinfect all of our tonometer prisms. For a while they were following your recommended sodium hypochlorite protocol, but they just hired three new technicians. We now have produced three corneal burns and have frequently rejected prisms that had a residue on the ocular surface. If that wasn't bad enough, we now have more than 11 prisms that will no longer fit into the retaining ring on the tonometer arm. They are bloated. I have asked sps if they were autoclaving the prisms; they have denied the use of steam. So, what else could cause this effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000176188-2016-00001 |
| MDR Report Key | 5623928 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-02 |
| Date of Report | 2016-04-29 |
| Date of Event | 2015-12-28 |
| Date Facility Aware | 2016-01-05 |
| Report Date | 2015-12-28 |
| Date Reported to Mfgr | 2015-12-28 |
| Date Mfgr Received | 2015-12-28 |
| Date Added to Maude | 2016-05-02 |
| 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 | MR. BEAT HUGI |
| Manufacturer Street | GARTENSTADTSTRASSE 10 |
| Manufacturer City | KOENIZ, CH-3098 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-3098 |
| Manufacturer Phone | 4131978011 |
| Manufacturer G1 | HAAG-STREIT AG |
| Manufacturer Street | GARTENSTADTSTRASSE 10 |
| Manufacturer City | KOENIZ, CH-3098 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-3098 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDMANN TONOMETER PRISM |
| Generic Name | TONOMETER PRISM (21 CFR 886.1930) |
| Product Code | HKY |
| Date Received | 2016-05-02 |
| Model Number | NONE |
| Catalog Number | 1902615 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAAG-STREIT AG |
| Manufacturer Address | GARTENSTADTSTRASSE 10 KOENIZ, CH-3098 SZ CH-3098 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-02 |