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

Model Number PL579T

Device Problem Unintended Ejection (1234)

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

Event Date 12/06/2023

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 the product pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, there was an intraoperative firing problem.The clip applier successfully fired and clipped twice.Further use caused the clips to back-up in cartridge, and finally stop loading.Some clips had fallen into the patient, but had been retrieved.This occurred during bariatric gastric bypass surgery and caused a delay of 20 minutes.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference 100034572 (400633030).Associated medwatch-reports: 9610612-2023-00273 (400633029 + pl520r) 9610612-2023-00275 (400633085 + pl536r).

Manufacturer Narrative

Additional information: d4 - batch and expiration date.H3 - evaluation, yes.H4 - manufacture date.H6 - codes updated.Investigation results: the challenger handle (b)(6) as well as the challenger shaft (b)(6) were provided for investigation.They were received in an overall good condition.No obvious damages could be detected.Further, an originally packaged clip cassette (b)(6) / lot 52835145 was received.The used clip cassette from the surgery was not received for investigation.The functional inspection of all three sent in system components did not reveal any deviation.The clips could be applied without issues.The reported issue of jamming or firing issues could not be reproduced.The jaw width of the shaft ((b)(6)) was found to be within specification.No anomalies noted on the challenger handle ((b)(6)).Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) 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) for leading components.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: based upon the above mentioned investigation results, the reported issue could not be reproduced.No failure of the returned challenger system was detected.Based upon the investigation results, a capa is not required.

Event Description

Associated medwatch-reports: 9610612-2023-00273 (internal aesculap ag ref.No.(b)(4) - pl520r).9610612-2023-00274 (internal aesculap ag ref.No.(b)(4) - pl579t).9610612-2023-00275 (internal aesculap ag ref.No.(b)(4) - pl536r).

• Brand Name: CHALLENGER TI-P ML-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: 18409917
• MDR Text Key: 331509900
• Report Number: 9610612-2023-00274
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52835145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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
• Patient Outcome(s): Required Intervention