MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-02 for SCISSORS, 5FR SEMI FLEX 0502555300 manufactured by Stryker Endoscopy San Jose.
[19653595]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[19728485]
It was reported that during a diagnostic hysteroscope procedure, the cable that tightens the jaw opening of the scissors broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936485-2012-00361 |
| MDR Report Key | 2654224 |
| Report Source | 07 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-07 |
| Date of Event | 2012-05-30 |
| Date Mfgr Received | 2012-06-07 |
| Date Added to Maude | 2012-10-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TOM SHAFER |
| 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 | SCISSORS, 5FR SEMI FLEX |
| Generic Name | SCISSORS |
| Product Code | HRR |
| Date Received | 2012-07-02 |
| Returned To Mfg | 2012-06-14 |
| Catalog Number | 0502555300 |
| Lot Number | 1042451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-02 |