MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LIGATION / VESSEL CLIPS

Model Number PL574T

Device Problem Accessory Incompatible (1004)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 06/11/2020

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 challenger ti-p sm-ligatur clips.According to the complaint description clips fell out of cartridge without being fired.Clips were retrieved and procedure was continued.Cartridge was discarded after surgery.There was no patient harm.Additional information was not provided.The malfunction is filed under aag reference (b)(4).Involved components: pl520r - challenger ti-p handle, pl522r - shaft compl.D:5mm l:310mm.

Manufacturer Narrative

Investigation results: to date this is an investigation without product.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.On the basis of the current information and without investigation of the product, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.

Event Description

Intra-operative medical intervention was necessary (x-ray).The malfunction is filed under aag reference (b)(4).Involved components: pl520r: challenger ti-p handle - batch: unknown; pl522r: shaft compl.D:5mm l:310mm - batch: 62331589.

Manufacturer Narrative

The complaint had been re-assessed for additional medical intervention (previously reported with preliminary investigation).Investigation results: the device was provided for investigation.Investigation was carried out visually.Investigation and tests were carried out by the production plant.Device passed all functional tests.No deviations can be found at the provided applier.The provided cartridges are damaged, the proximal ends are broken off, the fragments are not available for investigation.Distal ends of the sliding sheets are deformed.The device quality and manufacturing history records (dhr) have been checked for the 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.Based on the provided information and without a product for investigation, a clear conclusion can not be drawn.Due to the investigation results we assume a usage related error.To avoid the described error, the instructions for use must be observed.Replace the cartridge with a new one with every titanium clip cassette change based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10307949
• MDR Text Key: 203522668
• Report Number: 9610612-2020-00357
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• 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: 10/30/2020

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 Model Number: PL574T
• Device Catalogue Number: PL574T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/14/2020; 10/07/2020
• Supplement Dates FDA Received: 09/11/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL520R - UNKNOWN BATCH; PL520R - UNKNOWN BATCH; PL522R - UNKNOWN BATCH; PL522R - UNKNOWN BATCH
• Patient Outcome(s): Required Intervention