MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LAPAROSCOPIC SURGERY

Model Number	PL574T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on going.Additional information / results will be submitted in a supplemental report.
Event or Problem Description
It was reported that there was an issue with challenger ti-p sm-ligat.Clips 12 cartr.According to the customer description, it was reported that during pancreatic surgery the cartridge was used and found that the cartridge was broken when they tried to use it and it fell into the patient's abdomen.The surgeon found it right away, and there has been a surgical delay for 5-10 minutes to replace with new cartridge.It was noted that there was no harm to the patient.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Common Device Name: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10586815
• Report Number: 9610612-2020-00538
• Device Sequence Number: 11520128
• Product Code: FZP
• UDI-Device Identifier: 04046963356057
• UDI-Public: 4046963356057
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2024
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52544562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other