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

Model Number PL569T

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the product is not available for investigation.The investigation was carried out on the basis of the product photos provided for the article.Here we found a deformed metal sheet, deformed latches of the metal sheet and four of eight clips in the cartridge.According to customer information, an attempt was made to insert the clip magazine into the applicator during the operation.It was difficult to insert the clip magazine and as a result the applicator could not be closed.The magazine was then removed and a new applicator was used.With this second applicator the clips could be successfully applied.The first applicator was then loaded with a new magazine and the clips were successfully applied.The error was discovered before application to the patient.It can be expected that the magazine was improperly inserted into the applicator and that the clip magazine was deformed as a result.For this reason, the clips could not be applied properly.The device quality and manufacturing history records have been checked for the lot number (52463970) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.After completion of the investigation, an usage error is likely.The instructions for use indicate correct insertion of the clip magazine.In addition, a function test must be performed after changing the clip magazine.According to the quality standard a material defect and production error can be excluded.The current error rate is within the accepted error rate defined in the risk analysis.

Event Description

It was reported that there was an issue with ligating clips.The ligature clip used in laparoscopy to clamp vessels or others is defective.The instrumentalist and surgeon, after using one in the field, reported that it did not fit very well on the clamp and did not close well.So it was disassembled and another device was used.No consequence, but possible serious consequences.There was no patient harm reported.The malfunction is filed under aag reference (b)(4).

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION CLIPS MULTI-FIRE TITANIUM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8965477
• MDR Text Key: 156655930
• Report Number: 9610612-2019-00580
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52463970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1