MAUDE Adverse Event Report: AESCULAP AG CLIP APPLIER FORC.MEDIUM 200MM 25°; LIGATION / VESSEL CLIPS

Model Number FB235R

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 04/04/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with fb235r - clip applier forc.Medium 200mm 25°.According to the complaint description, the clips fell into the patient's abdomen.Each time, the clips were retrieved.This occurred during an unspecified procedure, after pressing lightly on the handles before applying forceps to the anatomical structure.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch reports: 400551296 fb240r - ( 9610612-2022-00102), 400551297 fb246r - ( 9610612-2022-00103), 400551298 fb235r - ( 9610612-2022-00104).

Manufacturer Narrative

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

Event Description

Associated medwatch reports: 400551296 fb240r - ( 9610612-2022-00102), 400551297 fb246r - ( 9610612-2022-00103), 400551298 fb235r.

Manufacturer Narrative

Investigation results: visually: the instruments were in a used condition, visually no deviations or defects could be detected.The instruments were forwarded to the manufacturing area for examination.Excerpt from the reports are within the linked ccs: the jaws of the application pliers were checked with the gauge for accuracy of the jaw position and are ok.In the production, the clamps were checked with the clip.If the handling is carried out correctly, the function is 100%.No error can be detected on the production side.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.There are no similar complaint against the same lot number(s) with this error pattern.Explanation and rationale: based on the investigation results, no defects could be detected.Conclusion and measures / preventive measures: based upon the investigation results, a clear root cause conclusion cannot be determined.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: CLIP APPLIER FORC.MEDIUM 200MM 25°
• 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: 14240580
• MDR Text Key: 294647639
• Report Number: 9610612-2022-00104
• 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
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB235R
• Device Catalogue Number: FB235R
• Device Lot Number: 52693566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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
• Patient Outcome(s): Required Intervention