MAUDE Adverse Event Report: AESCULAP AG INJECTION CANNULA SHARP 370MM LL; SUCTION AND IRRIGATION ACCESSORIES

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 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.
Additional Manufacturer Narrative
Updates: d9: ( return to manufacture).Corrections: f11, f13 & f14.Investigation results: reference code: sr554r, device name: injection cannula sharp 370mm ll, serial number: n/a, batch number: unknown, udi device identifier: (b)(4), udi production identifier: unknown, basic udi-di: (b)(4), unit of use udi-di: (b)(4), manufacturing date: unknown.Investigation: investigator carried out the pictorial documentation visually and microscopically.A pressure mark can be found at the point of the broken working end.This mark was most likely, caused by an overload situation, e.G.Excessive leverage, during application or reprocessing.And therefore, the thin working end is broken off.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 root cause: the root cause of the problem is most probably usage related.There is no capa necessary.
Event or Problem Description
No updates.

• Brand Name: INJECTION CANNULA SHARP 370MM LL
• Common Device Name: SUCTION AND IRRIGATION ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10924435
• Report Number: 2916714-2020-00695
• Device Sequence Number: 19467577
• Product Code: GCX
• UDI-Device Identifier: 04038653187478
• UDI-Public: 4038653187478
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 11/30/2020

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2020
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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
• Date Report Sent to FDA: 11/30/2020