MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-11 for DOUBLEAIRHOSE L5M F/SYST SYNTHES 519.530 manufactured by Umkirch.
[90078330]
(b)(4). Device manufacture date: the device manufacture date is unavailable. The manufacturing location is currently not available. (b)(6). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[90078351]
This is report 3 of 3 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the battery handpiece device did not work while in use with a lid device. It was reported that the surgeon changed to another handpiece device; however, the hose had a leak. It was further reported that the handpiece device was changed again and the surgery was completed. There was a thirty minute delay to the surgical procedure. There was patient involvement reported. It was reported that there was no consequence to the patient. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[117020919]
(b)(4). The manufacturer location was documented as unknown in the initial report. The location has been updated to (b)(6). Contact office name/address has been updated accordingly to reflect the corrected manufacturing facility. Device manufacture date: the device manufacture date was documented as unknown in the initial report. The device manufacture date has been updated as jun 7, 2001. Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. It was determined that the hose was leaking and the hose couplings were heavily worn and leaky. It was determined that the inner hose was broken from the coupling head. It was further determined that the device failed pretest for function check coupling and nipple for any leakage, perform pressure test for double air hose no leakage and perform pressure test for single air hose no leakage. The assignable root cause was determined to be due to wear from normal use and servicing. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2017-15421 |
| MDR Report Key | 6941458 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2001-06-07 |
| Date Added to Maude | 2017-10-11 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | UMKIRCH |
| Manufacturer Street | IM KIRCHENHURSTLE 4 |
| Manufacturer City | UMKIRCH B. FREIBURG D-79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEAIRHOSE L5M F/SYST SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-10-11 |
| Returned To Mfg | 2017-10-17 |
| Catalog Number | 519.530 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMKIRCH |
| Manufacturer Address | IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG D-79224 GM D-79224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |