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

Model Number PL579T

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/23/2021

Event Type  malfunction  

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 cartridge fell into patients stomach during surgery.The patient harm is unknown.The cartridge was retrieved without the assistance of x-ray.Additional information was not provided.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Updated h6 codes.Investigation results: visual investigation: the products arrived in a decontaminated condition and are available for investigation.We detected a broken off nose, bent latches of the slider sheet and we also detected a clip jam.Batch history review: the device quality and manufacturing history records (dhr) 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.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of the risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is no longer acceptable.The need to revisit the risk assessment will be requested and further evaluated by the responsible department.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.Usage-related failure could be possible.Based upon the investigations results a product saftey case was initiated - (b)(4).Any action regarding capa will be addressed with this case.

• 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
• MDR Report Key: 11554331
• MDR Text Key: 251234219
• Report Number: 9610612-2021-00218
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52654139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1