MAUDE Adverse Event Report: AESCULAP AG YASARGIL APPL.FCPS STD.PHYN.50/175MM; INSTR./ACCESS.YASARGIL PHYNOX

Model Number FE580K

Device Problem Mechanical Problem (1384)

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

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product yasargil appl.Fcps std.Phyn.50/175mm.The yasagril clip applier would pick up clips but not release them.This is a brand new applier that has not been used before.This incident did occur in surgery.This incident did not cause or contribute to serious injury or death or a delay in surgery.From the sterile processing department, no additional intervention was required at the time of the incident.There was no patient harm.No additional intervention mentioned on the submission.Additional information was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Due to the clarification after reviewing investigation results, the report was reassessed and found to no longer require submission - no malfunction or serious injury.Investigation: failure description - the instrument arrived in a clean status with a bent spring fe580401.Visual investigation - the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the instrument.Here we found a bent spring fe580401.Additionally we found a quirk and traces of usage.Furthermore we made a functional test of the lock.Due to the bent spring, the operating of the permanent lock is not satisfied.Batch history review - the device quality and manufacturing history records have been checked for the lot number (52517560) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - the root cause of the problem is most probably reprocessing related.Rationale - according to the quality standard and dhr files a material defect and production error can be excluded.Since the function of the lock is subject to a 100% inspection a delivery condition with poor function is excluded.According to guardus test plan: "lock function: lock softly engages and disengages.When the pliers are closed, the catch engages from the first to the second latching stage.Further pressing must release the ratchet lock into the first latching position." investigations lead to the assumption that the bent spring was caused by an improper handling by reprocessing.The instrument is not sterilized in its delivery state.Therefore the initial sterilization is carried out by the customer.The caused for the quirk could not be determined.Furthermore according the instruction for use the following points must be observed: clean the new product mechanically after removing its transport packaging and prior to its initial sterilization.Prior to each use, inspect the product.Do not use the product if it is damaged or defective - set it aside.Replace any damaged components immediately with original spare parts.After each complete cleaning, disinfecting and drying cycle, check the instrument is dry, clean, operational and free of damage.- check the product functions correctly.- immediately put aside damaged or inoperative products and send them to aesculap technical service (ats).No capa is required.

• Brand Name: YASARGIL APPL.FCPS STD.PHYN.50/175MM
• Type of Device: INSTR./ACCESS.YASARGIL PHYNOX
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9087061
• MDR Text Key: 159176205
• Report Number: 9610612-2019-00642
• Device Sequence Number: 1
• Product Code: HCI
• Combination Product (y/n): N
• PMA/PMN Number: K833651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FE580K
• Device Catalogue Number: FE580K
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1