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 07/14/2022

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 clips misfired.The clip cartridge started to misfire, then eventually fell off inside of the patient.The cartridge was then retrieved, and another one was used.This happened multiple times.An additional medical intervention was required.The malfunction occurred during a radical prostatectomy procedure.There was a slight surgical delay of 2-3 minutes.The patient outcome was "fine".The adverse event / malfunction is filed under aag reference 100031151.Involved components: 400562733 - pl606r - multif.Clip appl.Ti-p 10/370mm f/ml-clip.400562734 - pl606r - multif.Clip appl.Ti-p 10/370mm f/ml-clip.Associated medwatch reports: (b)(4) (9610612-2022-00219) (b)(4).(b)(4) (9610612-2022-00218) (b)(4).(b)(4) (9610612-2022-00217) (b)(4).(b)(4) (9610612-2022-00216) (b)(4).(b)(4) (9610612-2022-00215) (b)(4).(b)(4) (9610612-2022-00214) (b)(4).(b)(4) (9610612-2022-00213) (b)(4).

Event Description

Update: involved components: 400562733 - pl536r - shaft compl.D:10mm l:370mm 400562734 - pl536r - shaft compl.D:10mm l:370mm 400573781 - pl520r - challenger ti-p handle/lot unknown 400573782 - pl520r - challenger ti-p handle/lot unknown associated medwatch reports: 400562736 (9610612-2022-00219) pl579t 400562737 (9610612-2022-00218) pl579t 400562739 (9610612-2022-00217) pl579t 400562740 (9610612-2022-00216) pl579t 400562741 (9610612-2022-00215) pl579t 400562742 (9610612-2022-00214) pl579t 400562743 (9610612-2022-00213) pl579t.

Manufacturer Narrative

Additional information: b5 & d10 involved components updated d9 - product return date investigation: visual investigation: here we detected misaligned jaws.Furthermore, products have been forwarded to the responsible production department for further analysis.Pl536r were received, and one was not within specification due to misaligned jaw, not acceptable cartridge retention force and td *03/*04 are outside our allowable tolerance.Batch history review: due to the fact that no lot number was provided, a review of the device history records (dhr) for the complained device is not possible.The review of risk assessment revealed that the overall risk level ((3)5 severity x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: unfortunately, due to a lack of data a review of the dhr history record is not possible.Investigation leads to the assumption that the cause for the mentioned deviation was caused by an improper handling.If the product was tilted in the basket during reprocessing, there is the possibility that the jaws misaligned, and a further clip feeding is no longer possible.Furthermore, 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 cartridge to jump off.Based upon historically grown product experience and due to different simulation regarding a cartridge which is engaged not completely, this leads to the described errors.Conclusion and measures /preventive measures: based upon the investigation results, the root cause of the problem cannot clearly be determined.There is no indication for a material or design-related failure.Based upon the investigation results, a capa is not necessary.

• 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: 15200677
• MDR Text Key: 297685994
• Report Number: 9610612-2022-00218
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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
• Treatment: PL520R - CHALLENGER TI-P HANDLE/LOT UNKNOWN; PL520R - CHALLENGER TI-P HANDLE/LOT UNKNOWN; PL536R - SHAFT COMPL.D:10MM L:370MM; PL536R - SHAFT COMPL.D:10MM L:370MM; PL606R - MULTIF.CLIP APPL.TI-P 10/370MM F/ML-CLIP; PL606R - MULTIF.CLIP APPL.TI-P 10/370MM F/ML-CLIP
• Patient Outcome(s): Required Intervention
• Patient Sex: Male