MAUDE Adverse Event Report: AESCULAP AG TC CONVERSE NEEDLE HOLDER SERR 130MM; GENERAL SURGICAL INSTRUMENTS

Model Number BM011R

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 a needle holder.The following information was reported: needle holder failed inspection process for not gripping suture properly.Thee was no patient involvement.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.A visual inspection was carried out based on the qstd document "sa-dddd- m-5-2-04-149-0-h-en - version: 8.0".Several deviations (gaps and unevenness) can be found all over the solder joint and the jaw parts are not closing according to the specifications.The tips of the working ends are not symmetrically.Furthermore, the closing force with approximately 160 gram3 is outside the specified range.The instrument will be sent to the production plant for further investigation.This report will be updated as soon as the investigation results are available.Batch history review: the device quality and manufacturing history records have been checked for the available lot numbers and found to be according to our specifications valid at the time of production.One similar incident has 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 an a manufacturing error.Rationale: the needle holder was not manufactured according to the quality standard.Refer to investigation.Corrective action: a capa is not necessary.The instrument will be sent to the production plant for further investigation.

• Brand Name: TC CONVERSE NEEDLE HOLDER SERR 130MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9604877
• MDR Text Key: 179491071
• Report Number: 9610612-2019-00921
• Device Sequence Number: 1
• Product Code: HXK
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM011R
• Device Catalogue Number: BM011R
• Device Lot Number: 4510473564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/19/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1