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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG TC RYDER NEEDLE HOLDERX-DELSERR175MM; BASIC INSTRUMENTS

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AESCULAP AG TC RYDER NEEDLE HOLDERX-DELSERR175MM; BASIC INSTRUMENTS Back to Search Results
Model Number BM056R
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 05/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Investigation: vigilance investigation carried out the pictorial documentation visually and microscopically.Both carbide inlays are not in place, only one has been provided.The provided carbide inlay is matching with the jaw part "a".The surface of jaw part "a" is even and without deviation, while at part "b" several small pressure marks can be found.These pressure marks were most likely caused during using a needle, after the inlay had already fallen off.It is not possible to determine when the inlay has fallen off.At the surfaces of the jaw, no solder resides can be found.Therefore, we assume that the solder joint was not manufactured according to the specifications valid at the time of production.No other similar complaint are listed, therefore we assume an individual issue.Batch history review: the device quality and manufacturing history record have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to a manufacturing error.Corrective action: no other similar complaint, therefore we assume an individual issue.The q-coordinator of the production plant will be informed ad requested to initiate corrective measures.
 
Event Description
It was reported the jaw insert came loose and remained in situ.The reporter indicated that both carbide inserts of the needle holder became loose during surgery and fell off.One carbide insert was retrieved the other one wasn´t found.Therefore there is a possibility that it remained in situ.During cardiac surgery after the first stitch, the needle holder was opened and the surgeon recognized a part that had fallen into the patient.The part could be retrieved immediately and was 1mm wide and 5mm long.It also showed that the inserts were missing on both sides of the needle holder jaw.The entire in situ was examined after the second insert.In order to exclude anything remained in the vessel, an arterial flushing with saline solution was performed.Several x-rays were taken to further exclude the foreign body from remaining in situ.No foreign bodies were detected, however, since the broken part was still not found, a potential retention of the part in the patient cannot be completely excluded.
 
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Brand Name
TC RYDER NEEDLE HOLDERX-DELSERR175MM
Type of Device
BASIC INSTRUMENTS
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
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
8002581946
MDR Report Key8660350
MDR Text Key146813019
Report Number9610612-2019-00362
Device Sequence Number1
Product Code HXK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/31/2019
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
Device Operator Health Professional
Device Model NumberBM056R
Device Catalogue NumberBM056R
Device Lot Number4507422606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/21/2019
Device Age36 MO
Initial Date Manufacturer Received 05/02/2019
Initial Date FDA Received05/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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