MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LIG.CLIP XL W/LATCH; LIGATION / VESSEL CLIPS

Model Number PL475SU

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Date 09/04/2020

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 ligature clips.According to the complaint description the clips slipped out post surgery.The patient went through laparoscopic appendicitis surgery a year ago (unknown date of surgery), with clipping procedure to appendix root using ds clip.The patient had x-ray examination on 4th sept.Where three clips were found to have slipped out of the clipping site.Two out of three were closed tight and, obviously, these two clips slipped out of the appendix root.The other one clip most likely fell into the abdomen before clip was closed with applying forceps because the clip is not closed.At the moment we have not heard of surgical intervention for removal of the clips.So no sample is available.No current health hazard was reported, except for the three clips remaining in the patient.The patient harm is currently unknown.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation no products available.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.No product available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot be determined.

Event Description

Additional information received on oct 12, 2020.No surgical intervention is scheduled and there is no way to contact the patient for identification of the clip.

• Brand Name: DS-SINGLE FIRE LIG.CLIP XL W/LATCH
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10593934
• MDR Text Key: 208793382
• Report Number: 9610612-2020-00579
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K102081
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL475SU
• Device Catalogue Number: PL475SU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1