MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LAP.APPLIER XL 12/310MM; LIGATION / VESSEL CLIPS

Model Number PL809R

Device Problem Unintended Ejection (1234)

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

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported that there was an issue with pl809r - ds-single fire lap.Applier xl 12/310mm.According to the complaint description, the clip fell out of the applier.The clip could be recovered.An additional medical intervention was required.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Involved components: pl475su - ds-single fire lig.Clip xl w/latch - batch 52672647.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Correction: the original awareness was date 22jun2022; the initial mdr was not late, although awareness incorrectly reported as 16dec2021.

Manufacturer Narrative

Investigation: visual investigation:we detected that coating of the handles have signs of use (grinding marks).However the function of the product could be tested.The closing function of pliers with 3 clips each (pl475200) are within the specification.In addition we measured the gap dimension and these are also within the specification.There are no abnormalities.There is no indication for a manufacturing related error.The product was repaired in 2018 in our aesculap technical department.After the repair, a function test is always carried out.In case of any abnormality, the product would not go out to the customer, there is also an indication that the product was witin specification until now.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/measures: based upon the investigation results, the product is within the specifications.There is no indication for a manufacturing, material or design-related failure.Based upon the investigation results, a capa is not necessary.

Event Description

Involved components: pl475su - ds-single fire lig.Clip xl w/latch - batch 52672647.

• Brand Name: DS-SINGLE FIRE LAP.APPLIER XL 12/310MM
• 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: 14843822
• MDR Text Key: 295121040
• Report Number: 9610612-2022-00181
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL809R
• Device Catalogue Number: PL809R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PL475SU - DS-SINGLE FIRE LIG.CLIP XL W/LATCH.; PL475SU - DS-SINGLE FIRE LIG.CLIP XL W/LATCH.
• Patient Outcome(s): Required Intervention