MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for PORTAL ENTRY KIT CAT00241 manufactured by Stryker Endoscopy-san Jose.
[106162659]
The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. Alleged failure: guidewire snapped. Probable root cause: design stackup interference, material selection too weak to facilitate insertion/assembly of instruments manufacturing, cannula, guide wire or capsule punch not manufactured to specification application, excessive force, user unfamiliarity with device(s). The device manufacturer date is not known. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106162660]
It was reported that the guide wire broke in the anchor. The wire was removed from the anchor and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00354 |
| MDR Report Key | 7448646 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-04-20 |
| 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. VALERIE ESTRADA |
| 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 | 0 |
| Brand Name | PORTAL ENTRY KIT |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-04-20 |
| Catalog Number | CAT00241 |
| Lot Number | 002924 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-20 |