MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-09-16 for STRYKER C-MOUNT COUPLER 0988-020-122 N/ manufactured by Stryker Endoscopy.
[294151]
During a case, the picture was foggy and out of focus. The surgeon perforated a portion of the esophagus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936485-2003-00043 |
| MDR Report Key | 485322 |
| Report Source | 07 |
| Date Received | 2003-09-16 |
| Date of Event | 2003-06-20 |
| Report Date | 2003-06-20 |
| Date Mfgr Received | 2003-06-27 |
| Date Added to Maude | 2003-09-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 5900 OPTICAL CT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER C-MOUNT COUPLER |
| Generic Name | VIDEO COUPLER |
| Product Code | FTS |
| Date Received | 2003-09-16 |
| Model Number | 0988-020-122 |
| Catalog Number | N/ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 474208 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT. SAN JOSE CA 95138 US |
| Baseline Brand Name | STRYKER C-MOUNT COUPLER |
| Baseline Generic Name | VIDEO COUPLER |
| Baseline Model No | 0988-020-122 |
| Baseline Catalog No | N/ |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-16 |