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

Model Number PL569T

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2020

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 ligating clips.According to the complaint description the clips were ejected incorrectly into the abdomen.During laparoscopic cholecystectomy surgery, 5 clips were placed correctly at the level of cystic artery and the cystic duct.When placing the 6th clip the cartridge ejected from the handpiece, fell into the abdomen and 2 clips were released.The cartridge was removed with a laparoscopic forceps.An additional medical intervention was necessary.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was not returned for investigation.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number with this error pattern.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.

Manufacturer Narrative

Investigation results the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera "panasonic dmc tz8".We made a visual inspection of the product.Here we found a remaining clip - the last clip pl569211 clip medium-large coloured in the cartridge.Furthermore we detected a deformed latch of the slider sheet.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.According to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the deviation was caused during handling.The deformed latch of the slider sheet with no gap to the housing is an indicate for an usage related deviation.The dropped of cartridge could have caused due to the deformed latch.The exact cause for the deformed latch could not be determine.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10477368
• MDR Text Key: 205270913
• Report Number: 9610612-2020-00460
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52505380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 11/02/2020
• Supplement Dates FDA Received: 09/29/2020; 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention