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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG INJECTION CANNULA SHARP 370MM LL; SUCTION AND IRRIGATION ACCESSORIES
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AESCULAP AG INJECTION CANNULA SHARP 370MM LL; SUCTION AND IRRIGATION ACCESSORIES Back to Search Results
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 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.
 
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 Description
No updates.
 
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Brand Name
INJECTION CANNULA SHARP 370MM LL
Type of Device
SUCTION AND IRRIGATION ACCESSORIES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10924435
MDR Text Key218914775
Report Number2916714-2020-00695
Device Sequence Number1
Product Code GCX
UDI-Device Identifier04038653187478
UDI-Public4038653187478
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 11/30/2020,02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSR554R
Device Catalogue NumberSR554R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2020
Distributor Facility Aware Date11/02/2020
Device Age16 MO
Event Location Hospital
Date Report to Manufacturer11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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