MAUDE Adverse Event Report: AESCULAP AG SUCTION/IRRIGATION INSTRUMENT 5MM/330MM; VISUAL SYSTEMS & EQUIPMENT

Model Number PG027R

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that there was an issue with pg027r - suction/ irrigation instrument 5 mm/330 mm.According to the complaint description, the product was bent and broken during surgery.There was a surgical delay.Additional details have been requested.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation results: visual: at first sight it could be determined that the tip of the instrument was broken.The irrigation and suction channel is broken about 5 mm after the distal end.The tip of the needle shows pressure marks as well as on the shaft and on the cutting edge.The material around the fracture site shows deformations indicating a so-called vibration fracture.The fracture surface of both parts shows no anomalies such as blowholes or foreign body inclusions.Due to the small dimensions/diameter of the device, a detailed analysis of the fracture surface is difficult.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 1(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: there are no indications of a material or manufacturing defect.Based on our internal investigation, we assume that the tube was crushed and subsequently suffered a fatigue fracture, probably due to purpose alienation with a subsequent overload situation.Conclusion and measures / preventive measures: based upon the investigation results, the root cause is most probably usage-related.Based upon the investigation results, a capa is not necessary.

• Brand Name: SUCTION/IRRIGATION INSTRUMENT 5MM/330MM
• Type of Device: VISUAL SYSTEMS & EQUIPMENT
• 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: 15510837
• MDR Text Key: 302256665
• Report Number: 9610612-2022-00288
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PG027R
• Device Catalogue Number: PG027R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• 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