MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for FLAT-PANEL ROLL STAND BASE 0240099109 manufactured by Stryker Endoscopy-san Jose.
[23184265]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[23184266]
It was reported that the stand rolled over the back of the specialist's heel as she was pulling the stand, leaving a laceration that required 5 stitches on her upper heel.
Patient Sequence No: 1, Text Type: D, B5
[30644332]
The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. The complaint will be closed without a detailed investigation report and based on probable root cause. In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could have been caused by: manufacturing nonconformity ((b)(4)). Too much equipment. Loose / broken wheels. Damage during shipping /handling. Use error.
Patient Sequence No: 1, Text Type: N, H10
[30644333]
It was reported that the stand rolled over the back of the specialist's heel as she was pulling the stand, leaving a laceration that required 5 stitches on her upper heel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-00707 |
| MDR Report Key | 4974154 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-07-14 |
| Date Mfgr Received | 2015-07-14 |
| Date Added to Maude | 2015-08-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KIMBERLY LYNCH |
| 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 | FLAT-PANEL ROLL STAND BASE |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2015-08-05 |
| Catalog Number | 0240099109 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-08-05 |