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

Model Number PL569T

Device Problems Detachment of Device or Device Component (2907); Compatibility Problem (2960)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Investigation results: device was available for investigation.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.According to the quality standard and dhr files a production error and a material defect can be excluded.Based to the functional test no deviation could be found.Investigations lead also to the assumption that the described deviation was caused due to an usage error or maintenance error.If the cartridge is engaged not completely or has not been mounted correctly there is an impairment of product functionality.There could also be a possibility that the maintenance of the clip applicator has not been followed and may no longer meet the specifications.A capa is not necessary.

Event Description

It was reported that there was an issue with ligating clips m/l 12/box.According to the complaint description, several clips from the magazine simply fell out during loading, did not remain in the forceps as they should have.The clips fell into the abdomen, but could all be recovered.Another batch functioned.An additional medical intervention was necessary.The malfunction occurred during a cholecystectomy.The adverse event / malfunction is filed under aag reference (b)(4).Item: pl569t - batch: 52601209 - quantity: 9.

Manufacturer Narrative

"investigation results: visual investigation: we found an opened carton and nine closed sterile packaging.We made a functional test with one pl569t and no deviation could be found.Additionally the product was send to the quality assurance of the production department for further analysis.Should the investigation reveal new evidence, leading to a different conclusion, this report will be adapted.Batch history review: 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(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: on the basis of the current information and the investigation results, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.Based on the investigations and results of the 8d report a capa is not necessary.

• 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: 10528174
• MDR Text Key: 206761285
• Report Number: 9610612-2020-00530
• 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
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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
• Device Lot Number: 52601209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL569T - 52601209 -; PL569T - 52601209 -; PL569T - 52601209 -
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR