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

Model Number	SR554R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
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 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).
Additional 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
• Common Device Name: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10924265
• Report Number: 9610612-2020-00837
• Device Sequence Number: 14088048
• Product Code: GCX
• UDI-Device Identifier: 04038653187478
• UDI-Public: 4038653187478
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention