MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P CO2-CARTRIDGE ONLY; LIGATION / VESSEL CLIPS

Model Number PL575SU

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2020

Event Type  malfunction  

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 challenger ti-p co2-cartridge only.According to complaint description it was reported that one package was open and not sterilized.It was open on the opposite side from where it is normally opened.Also, there is no evidence of seal crimping in the open area.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under (b)(4).

Manufacturer Narrative

D section: updated lot number and expiration date investigation results after receipt of pictures: the device were not available for investigation, but pictures were sent.According to the available information, there were no negative consequences for the patient.On the basis of the images provided, it is not clear whether the seam has been sealed according to the specifications.A precise assessment can only be made after the product has been examined.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Without the product, an exact cause cannot be determined at this moment.Through our constant monitoring process, products and defects are continuously monitored.Based on the current data situation, no material or production faults are detectable.As mentioned above, for further investigations, the product is required for examination.

Manufacturer Narrative

Investigation lead to the assumption that the unsealed sterile packaging was may be caused by a deviation during manufacturing.It cannot be excluded that due to an individual employee error the sealing was not carried out and this was not detected during the inspection.

• Brand Name: CHALLENGER TI-P CO2-CARTRIDGE ONLY
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10101900
• MDR Text Key: 194008562
• Report Number: 9610612-2020-00177
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL575SU
• Device Catalogue Number: PL575SU
• Device Lot Number: 52576942
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1