MAUDE Adverse Event Report: AESCULAP AG ATR.INTESTINE.CLIP JAW LENGTH 70MM 3.94N; VESSEL CLIPS TEMPORARY

Model Number	PL541S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with pl541s - atr.Intestine.Clip jaw length 70mm 3.94n.According to the complaint description, the clip is misaligned.In laparo gastric surgery, an intestinal clip was grasped in the duodenum and the stomach was inflated with air under an endoscope.At that time, the clip fell off.When checked the clip, the clip was misaligned and has a gap of about 2 mm.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the clip provided is in a used condition.The jaws are not parallel and do not close completely.Vigilance investigator carried out the pictorial documentation visually and microscopically.The clip provided has been forwarded to the responsible q-coordinator of the production plant for investigation.Detailed investigation report attached to (b)(4).Based on this report, the closing force for as well as the position of the jaws are no longer according to specifications valid at the time of production.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.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: ATR.INTESTINE.CLIP JAW LENGTH 70MM 3.94N
• Common Device Name: VESSEL CLIPS TEMPORARY
• 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: 11495153
• Report Number: 9610612-2021-00167
• Device Sequence Number: 11886452
• Product Code: FFR
• UDI-Device Identifier: 04046963142476
• UDI-Public: 4046963142476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PL541S
• Device Catalogue Number: PL541S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown