MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-25 for ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER E705R manufactured by Ethicon Inc..
[2657289]
It was reported that a patient underwent an unknown procedure on (b)(6) 2012 and an endoscopic needle holder was used. During the procedure, the device would not release. There were no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[9927932]
(b)(4). Device will not release. Conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
[10486239]
Conclusion: the actual device was returned for evaluation. The spring of the ratchet mechanism was spent and the movable parts of the instrument were dry. After lubrication of the movable parts with an appropriate lubricant the ratchet mechanism functioned properly. According to information for use "after cleaning and prior to sterilization, lubricate all moving instrument parts with an appropriate lubricant. " user error caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-01785 |
| MDR Report Key | 2588365 |
| Report Source | 05,06 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-05-04 |
| Date of Event | 2012-05-02 |
| Date Facility Aware | 2012-05-02 |
| Date Mfgr Received | 2012-11-30 |
| Date Added to Maude | 2012-05-29 |
| 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 | 3 |
| Manufacturer Contact | MR. DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | ETHICON GMBH & COMPANY KG |
| Manufacturer Street | ROBERT - KOCH - STRASSE 1 PO BOX 1409 |
| Manufacturer City | D-22851 NORDERSTEDT NI |
| Manufacturer Country | GM |
| Manufacturer Postal Code | NI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER |
| Generic Name | MESH/ENDOS |
| Product Code | MFJ |
| Date Received | 2012-05-25 |
| Returned To Mfg | 2012-05-17 |
| Model Number | NA |
| Catalog Number | E705R |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-25 |