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

Model Number PL574T

Device Problems Unintended Ejection (1234); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a challenger ti-p sm-ligat.Clips 12 cartr (part # pl574t) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the clips were used to clip small blood vessels, but the cartridge floated and the next clip could not be loaded.This issue occurred three (3) times in a row.The doctor attempted to use a fourth cartridge, but the use was stopped.When the defective cartridges were checked, the claw at the base was found to be broken.The affected area was searched, but only one (1) of the three (3) clips were able to be retrieved.Although an inexperienced scrub nurse was in-charge, veteran staff instructed installation and operation of device.Reportedly, all settings were correct.The complaint device was returned to the manufacturer for evaluation.The patient has no infection, but the claw part of the cartridge might have fallen inside the body.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a challenger ti-p sm-ligat.Clips 12 cartr (part # pl574t) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the clips were used to clip small blood vessels, but the cartridge floated and the next clip could not be loaded.This issue occurred three (3) times in a row.The doctor attempted to use a fourth cartridge, but the use was stopped.When the defective cartridges were checked, the claw at the base was found to be broken.The affected area was searched, but only one (1) of the three (3) clips were able to be retrieved.Although an inexperienced scrub nurse was in-charge, veteran staff instructed installation and operation of device.Reportedly, all settings were correct.The complaint device was returned to the manufacturer for evaluation.The patient has no infection, but the claw part of the cartridge might have fallen inside the body.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information/correction: h6 - codes investigation results: visual investigation: we made a visual inspection of the product; here we detected a clip jam, deformed tip of the slider sheet, broken off latches and noses, and deformed latches of the slider sheet.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: if the cartridge is engaged not completely or was damaged during inserting, there is an impairment of product functionality.This could lead to deformed latches of the slider sheet, to clip jam and can cause the clip-cartridge to jump off.Additionally, the broken off nose/latches was most likely caused due to an improper removal of the clip cartridge or by exerting too much force into the tissue.Furthermore, according to the the instructions for use (ifu), the following points must be observed: function check; inserting the titanium clip cassette, and removing the titanium clip cassette.Malfunction of the titanium clip cassette due to use of the same cartridge for more than one cassette! ->replace the cartridge with a new one every titanium clip cassette change.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 investigation results, a capa is not required.

• 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: 13546124
• MDR Text Key: 286336167
• Report Number: 9610612-2022-00022
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04046963356057
• UDI-Public: 4046963356057
• 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: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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