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 Corp..
[19090850]
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 # (b)(4). Good faith effort attempts were made to the territory manager on (b)(6) 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)(6) 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 | 2518897-2015-00007 |
MDR Report Key | 4788005 |
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 CORPORATION |
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 CORP. |
Manufacturer Address | TOKYO JA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2015-05-20 |