MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P HANDLE; LIGATION / VESSEL CLIPS

Model Number PL520R

Device Problem Unintended Ejection (1234)

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

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

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 inc.That a challenger ti-p handle (part# pl520r) was used during a bariatric gastric bypass on (b)(6) 2023.According to the complainant the clip applier successfully fired and clipped twice.Further use of the clip applier caused the clips to back up in cartridge.Reportedly the staff tried again to engage the clip applier and 3 titanium clips dropped into the patient.The pieces were retrieved during surgery and removed from inside of patient.A delay of twenty minutes was reported as a result of this incident.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: 400633030 (2916714-2023-00126) pl579t, 400633085 (2916714-2023-00127) pl536r.

Manufacturer Narrative

Description of defect information received: io firing problem, sample product availability: yes, sample product quantity: 1 piece(s).Investigation: sample description: the challenger handle pl520r as well as the challenger shaft pl536r were provided for investigation.They were received in an overall good condition.No obvious damages could be detected.Further, an originally packaged clip cassette pl579t / lot 52835145 was received.The used clip cassette from the surgery was not received for investigation.Investigation procedure: the functional inspection of all three sent in system components did not reveal any deviation.The clips could be applied without issues.The reported issue of jamming or firing issues could not be reproduced.The jaw width of the shaft (pl536r) was found to be within specification.No anomalies noted on the challenger handle (pl520r).Conclusion and root cause: based upon the above mentioned investigation results, the reported issue could not be reproduced.No failure of the returned challenger system was detected.The complaint is not accepted.Device history record: 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.There are no similar complaints against the same lot number(s) for leading components.Corrective measure: decision for corrective measures: yes [ ] no [x].Description of corrective measures incl.Recommendations to customer, if applicable: n/a.Sales decision plant: not accepted-credit note for samples.

Event Description

Investigation complete.

Manufacturer Narrative

Additional information: f9 approximate age of device.

• Brand Name: CHALLENGER TI-P HANDLE
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18405328
• MDR Text Key: 331483229
• Report Number: 2916714-2023-00125
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04046963356026
• UDI-Public: 4046963356026
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2023,04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL520R
• Device Catalogue Number: PL520R
• Device Lot Number: 62520794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2023
• Distributor Facility Aware Date: 12/06/2023
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention