MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for PENTAX HS-D2622 manufactured by Hoya Corporation Pentax Tokyo Office.
[132779026]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132779027]
Pentax medical became aware of a report on (b)(4) 2018, stating the "internal wire of hemostat wide cup snapped while attempting to close forceps. Scope had to be removed from patient to recover device" of a pentax medical bi-polar hot hemostasis forceps model number hs-d2622, serial number: (b)(4). There was no adverse event to the user or patient was reported. The product is not available for return evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2019-00167 |
| MDR Report Key | 8219997 |
| Date Received | 2019-01-04 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-12-06 |
| Date Facility Aware | 2018-12-06 |
| Report Date | 2019-01-04 |
| Date Reported to FDA | 2019-01-04 |
| Date Reported to Mfgr | 2019-01-04 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2019-01-04 |
| 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. WILLIAM GOELLER (TEMPORARY) |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 8004315880 |
| Manufacturer G1 | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Street | TSUTSUJIGAOKA 1-1-110 |
| Manufacturer City | AKISHIMA-SHI, TOKYO 196-0012 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-0012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PENTAX |
| Generic Name | HEMOSTASIS FORCEPS |
| Product Code | EMD |
| Date Received | 2019-01-04 |
| Model Number | HS-D2622 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Address | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI, TOKYO 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |