MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION CLIPS MULTI-FIRE

Model Number PL569T

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Sepsis (2067); Patient Problem/Medical Problem (2688)

Event Date 06/15/2016

Event Type  Injury  

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 ligating clips m/l 12/box.According to the description of the complaint, the patient has experienced considerable harm as a result of a surgical treatment of gallstones.The cause of her problems, which manifested itself in a septic shock with all its consequences, is said to have been caused by the clip falling out of patient cystic duct; this caused a further outflow of gall bladder fluid into the abdominal cavity.The procedure performed had been a laparoscopic cholecystectomy and gallstone removal on a female patient on (b)(6) 2016.There was a life threatening situation.Additional information was not provided.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: product was not provided, therefore no investigation possible.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.Rationale: without the product we cannot determine the exact cause.If further investigations are required, the complaint product and clip applicator should be provided for examination.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION CLIPS MULTI-FIRE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10494883
• MDR Text Key: 206959739
• Report Number: 9610612-2020-00481
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: D021087
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening