MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy-san Jose.
[29985404]
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[29985445]
It was reported the mount arm on the stryker vision broke at the elbow.
Patient Sequence No: 1, Text Type: D, B5
[33590779]
The product was not returned for investigation at stryker endoscopy, therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.?? The device was not received for investigation at stryker endoscopy. It was evaluated at tekna. The evaluation results indicates: "we have evaluated this arm. It looks like what happened is that the pivot pins worked loose from one side of the arm, resulting in higher stress on the other side causing the part to break. We have had couple of complaints like this in the past and had traced it to a rare reaming operation at our supplier. Back in the 2004, early 2005 time period, if the operators had difficulty pressing in the pins, they would occasionally ream the holes a little larger. This allows the pin to come loose later. This operation is no longer performed at the supplier. Even in that condition, the arm lasted over ten years though. "
Patient Sequence No: 1, Text Type: N, H10
[33590780]
It was reported the mount arm on the stryker vision broke at the elbow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-00963 |
| MDR Report Key | 5180611 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-02 |
| Date of Event | 2015-09-29 |
| Date Mfgr Received | 2015-10-02 |
| Date Added to Maude | 2015-10-27 |
| 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 | STRYKERVISION FLAT-PANEL MOUNTING ARM |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2015-10-27 |
| Catalog Number | 0240095200 |
| Lot Number | 040330039 |
| 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 | 2015-10-27 |