MAUDE Adverse Event Report: AESCULAP AG HANDLE F/PL506R & PL508R; LIGATION / VESSEL CLIPS

Model Number PL510R

Device Problem Product Quality Problem (1506)

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

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 pl510r - handle f/pl506r & pl508r.According to the complaint description, the applicator gets stuck.Doctor replaced the applicator as soon as the error was noticed.There was no described patient harm.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00281 ((b)(4)).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: HANDLE F/PL506R & PL508R
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11602866
• MDR Text Key: 251246119
• Report Number: 9610612-2021-00280
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL510R
• Device Catalogue Number: PL510R
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1