MAUDE Adverse Event Report: AESCULAP AG INJECTION CANNULA SHARP 370MM LL; LAPAROSCOPIC SURGERY

Model Number SR554R

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2020

Event Type  Injury  

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 sr554r-injection cannula sharp 370mm ll.According to the complaint description, it was reported during total laparoscopic hysterectomy the needle tip suction sr554r broke off in patient and required a laparotomy to retrieve the tip.No patient harm was reported.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: a pressure mark can be found at the point of the broken working end.This mark was most likely caused by an overload situation.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 the root cause of the problem is most probably usage-related.Based upon the investigations results capa is not necessary.

• Brand Name: INJECTION CANNULA SHARP 370MM LL
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10924265
• MDR Text Key: 219183382
• Report Number: 9610612-2020-00837
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 04038653187478
• UDI-Public: 4038653187478
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SR554R
• Device Catalogue Number: SR554R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention