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

Model Number PL579T

Device Problem Unintended Ejection (1234)

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

Event Date 12/12/2022

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 pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the magazine has come loose in the patient during ongoing surgery.According to the deviation, the first clip has been inserted and in connection with it, the entire magazine has come loose from the clip bar in the abdomen and that plastic parts have also come loose from the magazine.The magazine and plastic parts could be removed via a working port.An additional medical intervention was necessary.This event prolonged the surgery for 30 minutes.The adverse event is related to aag reference 100032130; this complaint is aag reference 400580901.Involved components: 400582163 - pl520r - challenger ti-p handle - lot unknown.400582164 - pl538r - shaft compl.D:10mm l:260mm - lot 62455351.

Manufacturer Narrative

Additional information: b5 - involved components.D10 - involved components.H3 - device evaluation completed.H6 - codes updated.Investigation results: visual investigation: we received an original packed cartridge, but not the cartridge in question.Further, we received the shaft and the handle, but no deviations could be found visually.Only an original packed clip cartridge was sent in for testing, but not the cartridge in question.The cartridge provided was mounted on the applier and all the clips were applied to a test card successfully.Furthermore, the retention force was tested and was on target with 5.3 n (>4n).Therefore, the applier and the cartridge functioned according to the specification.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.Three similar incidents have been filed with products from this batch.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard and dhr files a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.Without knowledge "improper handling" can be named as a possible root cause for the reported issue.Various factors fall into this root cause category.For example, if the cartridge is not engaged completely to the shaft or if it is damaged during inserting, an impairment of product functionality occurs, in consequence, this could lead to deformed latches of the slider sheet, to mispositioned clips and ultimately to a clip jam as noted on the complaint sample.Further, it is possible that the noted clip jam occurs, if the clip application sequences is performed with excessive speed.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.

Event Description

Update: involved components: pl520r/ challenger ti-p handle - lot unknown (400582163) pl538r/shaft compl.D:10mm l:260mm - lot 62455351 (400582164).

• Brand Name: CHALLENGER TI-P ML-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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16063179
• MDR Text Key: 306315955
• Report Number: 9610612-2022-00382
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 52797612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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; PL520R - LOT UNKNOWN; PL538R - LOT 62455351; PL538R - LOT 62455351
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female