MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-22 for UNKNOWN_ENDOSCOPY_PRODUCT UNK_END manufactured by Stryker Endoscopy-san Jose.
[63170887]
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. Gtin:unknown.
Patient Sequence No: 1, Text Type: N, H10
[63170888]
It was reported that the medical procedure was converted to an open surgery and resulted in patient death.
Patient Sequence No: 1, Text Type: D, B5
[74708860]
Alleged failure: insufflation pressure was too high. Probable root cause: pressure sensor malfunction / out of calibration; software malfunction; use error; system design; unwanted movement of internal components / wiring; insufflator operated at least-favorable environmental conditions for an extended period of time. Pressure button does not disengage. 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 device manufacturer date is not known.
Patient Sequence No: 1, Text Type: N, H10
[74708861]
It was reported that the medical procedure was converted to an open surgery and resulted in patient death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-01207 |
| MDR Report Key | 6199955 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-22 |
| Date of Report | 2017-05-08 |
| Date of Event | 2014-10-02 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-12-22 |
| 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. 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 | UNKNOWN_ENDOSCOPY_PRODUCT |
| Generic Name | UNKNOWN |
| Product Code | GCQ |
| Date Received | 2016-12-22 |
| Catalog Number | UNK_END |
| Lot Number | UNK |
| 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 | 1. Death | 2016-12-22 |