MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-30 for KARL STORZ manufactured by Karl Storz Gmbh & Co. Kg.
[18852606]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19209759]
No ks product was returned because the hospital determined that it was a malfunction of the covidien force triad esu which caused excessive energy when instruments were activated resulting in the perforation. The unit was sent to covidien in (b)(4) 2013 for service for bad bipolar output. Covidien could not confirm that issue and performed calibration and preventative maintenance and returned unit to the hosp; no repairs were done. After the perforation occurred, unit was sent back again for eval. Covidien eval report provided to the hospital ((b)(4) 2013): hospital's stated reason for return: while doing a bipolar resection of the prostrate, the unit was not working properly. At low wattage, there was no power and when they put higher wattage it was too strong and the energy perforated the bladder. Covidien eval and repair text: received unit with no ecode and sw 3. 5. Last calibration performed (b)(4) 2013. During inspection we found a non-functional mechanism in the ligasure 2 port. Realignment of the mechanism fixed. Cannot read any deviation of the direct rf energy even the leakage current from 6 ports. All performance and verification done as recommended by mfg. New software installed (3. 6) complete inspection done. Esu passed pvt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2013-00036 |
| MDR Report Key | 3447095 |
| Report Source | 05 |
| Date Received | 2013-09-30 |
| Date Facility Aware | 2013-08-29 |
| Report Date | 2013-09-27 |
| Date Reported to FDA | 2013-09-27 |
| Date Reported to Mfgr | 2013-09-27 |
| Date Added to Maude | 2013-11-05 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG |
| Manufacturer Street | MITTELSTRASSE 8 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | BIPOLAR ELECTRODE |
| Product Code | HIN |
| Date Received | 2013-09-30 |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | MITTELSTRASSE 8 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-30 |