MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; HANDHELD PRODUCTS & LIGATION

Model Number PL574T

Device Problem Unintended Ejection (1234)

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

Event Date 03/31/2023

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 pl574t - challenger ti-p sm-ligat.Clips 12 cartr.According to the complaint description, the cartridge detached and dropped in the patient's body during a robotic hepatectomy.Also, the protuberance at the distal end was broken.The surgeon tried to find the fragment; however, it could not be found.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.This case is related to xc 100032824.The adverse event is filed under aag reference (b)(4) ((b)(4)).Involved components : pl522r - shaft compl.D:5mm l:310mm - lot unknown; pl520r - challenger ti-p handle - lot unknown.

Manufacturer Narrative

Investigation results: visual inspection: the complaint sample of the leading material (pl574t) was received in a used condition.Seven clips are left contained in the clip cassette.The latch is broken-off.The co2 cartridge was also provided in a used condition.The involved components (pl520r; pl522r) were not provided for investigation.The provided clip cassette exhibits a broken-off latch on the plastic housing.A clip jam or deformation on the slider sheet could not be detected.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 is one similar complaint against the same lot number (same customer).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, a definitive root cause cannot be established.There is no indication for a material defect or manufacturing failure.Based upon the investigation results, a capa is not required.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: HANDHELD PRODUCTS & LIGATION
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16777571
• MDR Text Key: 313662200
• Report Number: 9610612-2023-00079
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52786345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PL520R - LOT UNKNOWN.; PL522R - LOT UNKNOWN.
• Patient Outcome(s): Required Intervention