MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-01 for PENTAX KH-2422S manufactured by Pentax Corp..
[6263218]
Pentax medical received biopsy forceps with windows and spike model #kh-2422s/ serial # (b)(4) and a visual inspection was performed on 06/03/2015. The visual inspection confirmed breakage by the handle area. No other visual defects were noted. Good faith effort attempts were made to the initial reporter on 06/03/2015 and 06/11/2015 to confirm details of the event for the investigation and in order to be able to assess the event for reportability. A phone conversation was held with the initial reporter on (b)(4) 2015 who confirmed that the breakage occurred during procedure and no injuries to the pt or user occurred. Due to these additional details, the event was determined to be a reportable event on (b)(4) 2015. No other details surrounding the event were received from the initial reporter. Based on the info received from the initial reporter and the visual inspection performed by pentax medical, a root cause of the event cannot be determined at this time. The only possibilities are to suggest the user applied excessive force which resulted in the breakage or the breakage was a result of a mfg non-conformity. Since the root cause for this complaint is unk, a corrective action request was initiated for the mfr, along with sending the sample involved in this event, to further evaluate the product and implement any corrective actions, if necessary. Pentax medical has not received any other info regarding this event or the medical device involved, and therefore considers this medwatch report closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518897-2015-00016 |
| MDR Report Key | 4886427 |
| Report Source | 07 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-01-01 |
| Date Facility Aware | 2015-06-12 |
| Report Date | 2015-06-30 |
| Date Reported to FDA | 2015-06-30 |
| Date Reported to Mfgr | 2015-06-30 |
| Date Mfgr Received | 2015-06-12 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-07-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | ANASTASIA VLAMIS |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 2015712300 |
| Manufacturer G1 | HOYA CORP., PENTAX LIFE CARE TOKYO OFFICE |
| Manufacturer Street | 2-7-5 NAKA-PSJAO, SHINJUKU-KU |
| Manufacturer City | TOKYO 161-8525 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 161-8525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | BIOPSY FORCEPS WITH WINDOWS AND SPIKE |
| Product Code | GCL |
| Date Received | 2015-07-01 |
| Returned To Mfg | 2015-06-02 |
| Model Number | KH-2422S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTAX CORP. |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |