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

Model Number PL536R

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the complaint articles were available for investigation.The components are in a ood condition but the recommended maintenance dates were exceeded.Maintenance due: 06/2019.No visual deviations can be found during visual inspection and functional tests were carried out successfully.The appliers were forwarded to the responsible department for further investigations.This report will be updated as soon as the investigations are completed.The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from these batches.Based on the information available as well as a result of our preliminary investigation the root cause of the failure is most probably related to an insufficient usage.According to the statement of the sales rep, the failure was usage related.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Further investigations are ongoing and this report will be updated as soon as the investigations are completed.Furthermore to ensure reliable surgeries, aesculap (b)(4) recommends maintaining the products as indicated on the maintenance label.A capa was not initiated.

Event Description

It was reported that there was an issue with a challenger shaft.According to the complaint description ligature clips fell into patients abdomen intraoperatively.Type of surgery: gall bladder removal.The surgery took 45 minutes with no significant surgery delay.No patient harm was reported.All parts were directly removed from patients abdomen.The used cartridges were pl569t.Additional information received on 30 jun 2020: sales rep stated that during preparation two points were identified.If the cartridge is not loaded correctly, a jam may occur when the clips are loaded.Therefore the failure is maybe related to the user.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00279 (400476600 - pl536r).9610612-2020-00278 (400476599 - pl536r).Involved components: pl510r - handle f/pl506r & pl508r, batch: 62243673, pl510r - handle f/pl506r & pl508r, batch: 62243673, pl569t - ligating clips m/l 12/box, batch: unknown.

• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10283731
• MDR Text Key: 219183852
• Report Number: 9610612-2020-00278
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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
• Device Lot Number: 62242980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• 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