MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-20 for UNKNOWN_ENDOSCOPY_PRODUCT UNK_END manufactured by Stryker Endoscopy-san Jose.
[5591441]
The surgeon reported the following event : "5 hours after the surgery ( acromioplasty + tenodesis of the long part of the biceps under arthroscopy), a burn in the upper part of the forearm of the patient was observed".
Patient Sequence No: 1, Text Type: D, B5
[13093747]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[29928227]
The reported unit was not returned for evaluation. The customer did not report the serfas probe part number or lot number used. The most probable root causes for (heat- excessive heat delivered to body) when using a serfas energy probe, can be associated, but are not limited to: user error: suction not connected with pinch clamp left open which allows hot fluid to leak out of the suction tube; incorrect fluid management; probe clogged; pinch clamps left closed when suction is desired or open if suction is not being used; the product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[29928228]
The surgeon reported the following event : "5 hours after the surgery ( acromioplasty + tenodesis of the long part of the biceps under arthroscopy), a burn in the upper part of the forearm of the patient was observed".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-00178 |
| MDR Report Key | 4621825 |
| Report Source | 05 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-03-12 |
| Date of Event | 2011-03-31 |
| Date Mfgr Received | 2015-03-12 |
| Date Added to Maude | 2015-03-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS SHAFER |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_ENDOSCOPY_PRODUCT |
| Generic Name | UNKNOWN |
| Product Code | FSS |
| Date Received | 2015-03-20 |
| Catalog Number | UNK_END |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-20 |