MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number PL572T

Device Problem Failure to Form Staple (2579)

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

Event Type  malfunction  

Manufacturer Narrative

Associated medwatches: other cartridges reported separately.Manufacturing evaluation: investigation: we received a complaint about 6 challenger cartridges from four batches.Six broken 5 mm cartridges are available for investigation decontaminated.All were broken and deformed; the deformation may have been caused by reprocessing which is necessary to carry out an investigation.The pl606r is an applicator for the 10 mm cartridges, and we did not receive the 5 mm applicator.Visually, all cartridges showed a clip jam, 2 tips were broken off.Once cartridge was fractured approximately in the middle of the device.The analysis all fracture patterns illustrated forced fractures due to overload.No pores, inclusions or foreign bodies could be found on the points of rupture.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production.No similar incidents have been filed with products from the batches 52499423, 52496374 and 52501915.Two similar incidents have been filed with products from the batch 52491012.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the problem is most likely related to insufficient usage.Rationale: according to the quality standard and device history records (dhr) files a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation during mounting the cartridges on the applicator.There is a possibility for a too fast application, and therefore a proper transport of the clips can no longer be guaranteed.

Event Description

It was reported that there was an intraoperative issue with challenger clips.During an unspecified procedure, the clips were misfiring.The facility was concerned about a possible material defect or processing errors.Additional information was not provided, although it had been requested.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8836978
• MDR Text Key: 153826615
• Report Number: 9610612-2019-00481
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081031
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2024
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52491012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1