MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-20 for PENTAX KH-2422S manufactured by Hoya Corporation.
[5857192]
Pentax medical received a report from a territory manager on (b)(6) 2015 stating "during procedure, when trying to grab a biopsy in the patient, the handle snapped from the biopsy forceps. Another biopsy forceps was used to complete the biopsy". This event occurred with 2 separate biopsy forceps. The second event is captured under report # 2518897-2015-00008. Good faith effort attempts were made to the territory manager on (b)(4) 2015. The territory manager indicated the product is available for return, and also stated video gastroscope model eg-2990k was being used at the time the event occurred. A third good faith effort attempt regarding product return was sent to the territory manager on (b)(4) 2015. The product is currently pending return to pentax medical for evaluation. A corrective action request will also be submitted to the manufacturer to investigate the product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518897-2015-00008 |
| MDR Report Key | 4787986 |
| Report Source | 07 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-04-27 |
| Date Facility Aware | 2015-04-27 |
| Report Date | 2015-05-19 |
| Date Reported to FDA | 2015-05-19 |
| Date Reported to Mfgr | 2015-05-19 |
| Date Mfgr Received | 2015-04-27 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-05-22 |
| 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. |
| 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 | 2015-05-20 |
| Model Number | KH-2422S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-20 |