MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-22 for PORTAL ENTRY KIT CAT00241 manufactured by Stryker Endoscopy-san Jose.
[112050492]
Additional information will be provided once the investigation has been completed. The device manufacturer date is not known at this time. However, should it become available it will be provided in future reports.
Patient Sequence No: 1, Text Type: N, H10
[112050493]
It was reported that product broke during use. All broken pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00500 |
| MDR Report Key | 7629841 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-22 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-05-28 |
| Date Mfgr Received | 2018-05-28 |
| Date Added to Maude | 2018-06-22 |
| 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. ANDREA ZENERE |
| 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 | PORTAL ENTRY KIT |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-08-07 |
| Catalog Number | CAT00241 |
| Lot Number | LOT003116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-22 |