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 03/30/2023

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 clip came off and dropped in the patient's body after 5 to 6 shots clips were applied.This event occured during a robotic distal pancreatectomy.Finally the cartridge was detached and dropped in the patient's intraperitoneal.The surgeon decide to stop using this pl604r for the surgery.After the surgery, the function of this pl604r was checked and it was found out that clipping was carried out properly then.The surgeon decide to use the product again at the next surgery.However, on the next day, same defect occurred during another surgery.After the surgery a clipping test was carried out.The first clip could be loaded and shot properly but from the next clip, loading could not be done properly at all and could not be used at all.The gas pressure that was sent from the handle did not seem to be enough and proper.Another clipping test with another clip and co2 was perfomed with a cartridge again.Then the loading and clipping could be carried out properly.However, loading seemed to be slower.The tip of product seems to be deformed slightly.An additional medical intervention was necessary.This case is related to (b)(4).Additional patient information is not available.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 (1xpl574t) was received in a used condition.Eight clips are left in the clip cassette.A clip jam could not be detected.The nose and latch of the plastic housing is broken-off, the slider sheet is deformed.The co2 cartridges was also provided in a punctured condition.The involved components (pl520r; pl522r) were received without obvious defects.Both components are marked with aesculap technical services (ats), which indicates at least one prior repair in the aesculap technical service.During functional inspection of the instruments pl520r & pl522r using a new clip cassette (lot: 62107881) no deviation could be detected.The entire clip cassette could be applied without issues.The clip cassette was holding firmly on the complaint shaft.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.Pl574t: there is one similar complaints 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.The reported issue could not be reproduced during functional testing.The clip cassette was holding tightly on the shaft.The most relevant testing criteria (magazine retention force) was found above the required minimum value of 2newton (n).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: 16807489
• MDR Text Key: 313926332
• Report Number: 9610612-2023-00080
• 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

• Date FDA Received: 04/25/2023
• 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
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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
• Treatment: PL520R - LOT UNKNOWN.; PL522R - LOT UNKNOWN.
• Patient Outcome(s): Required Intervention