MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:10MM L:370MM; LIGATION / VESSEL CLIPS

Model Number PL536R

Device Problems Mechanical Problem (1384); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: a vigilance investigator carried out the pictorial documentation visually.Investigation was carried out by the responsible q-coordinator of the production plant.Gauge -retention force of the cartridge.Scale - tightness of the handle.Recommended maintenance date: exceeded (2017-02).Inspection dimension 04: current: 7,05 mm; target: 7,0 (-0.1, -0.3) mm.Inspection dimension 05: current: 6,65 mm; target 6,5 +0.1 mm.Retention force of the cartridge: ok.Functional test: passed.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rational: since the working ends of all shaft are damaged, they are no longer according to the specifications valid at the time of production.Therefore, a function according to specifications can no longer be guaranteed and is most likely the root cause of the mentioned failure.Damage to the working ends, in particular the jaws, could be caused by an overload situation, e.G.Leverage or torsion during the application or preparation.Furthermore, the recommended maintenance date of several components is exceeded.And should be observed.Technical service excerpt: risk of injury and/or malfunction! do not modify the product.No corrective/preventive actions needed.

Event Description

The reporter indicated the clips do not fire correctly.A request for additional information has been requested from the clinic, however, a response has not been received.Associated medwatches: 9610612-2019-00369, 9610612-2019-00371, 9610612-2019-00372, 9610612-2019-00376, 9610612-2019-00377, 9610612-2019-00378.9610612-2019-00379.

• Brand Name: SHAFT COMPL.D:10MM L:370MM
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8675938
• MDR Text Key: 147460173
• Report Number: 9610612-2019-00370
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL536R
• Device Catalogue Number: PL536R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2019
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1