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

Model Number PL574T

Device Problems Fracture (1260); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

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 pl574t - challenger ti-p sm-ligat.Clips 12 cartr.According to the complaint description, the cartridge detached.The clip was not filled and the claw at the base of the cartridge broke and disappeared.The fragment remained in situ.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Involved components: pl522r - shaft compl.D:5mm l:310mm - lot unknown.Pl520r - challenger ti-p handle - lot unknown.

Event Description

Involved components: pl522r - shaft compl.D:5mm l:310mm - lot unknown.Pl520r - challenger ti-p handle - lot unknown.

Manufacturer Narrative

Investigation results: visual investigation: the products arrived in a used condition.The investigation was carried out visually and microscopically.We made a visual inspection of the products, here we detected a deformed slider sheet and a broken off latch.In addition, we detected that the jaws are slightly bent and no longer according the dimensions according to our specification valid at the time of production (target: 3,3+0,1/ actual: 3,42 id: 33581).Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5)) according to din en iso (b)(4) is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12191592
• MDR Text Key: 262487651
• Report Number: 9610612-2021-00512
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52674383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PL520R - LOT UNKNOWN; PL520R - LOT UNKNOWN; PL522R - LOT UNKNOWN; PL522R - LOT UNKNOWN