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

Model Number BM012R

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Vigilance investigator carried out the pictorial documentation visually, and microscopically.Functional tests confirmed, the movement of the needle holders is very stiff due to metal seizure.Signs of wear and tear can be found at the lock of all provided needle holders.Furthermore, residues can be found all over the surfaces, most likely caused by insufficient reprocessing.According to the statement of the sales organization as well as the findings of the investigation showed, the instruments have been used and reprocessed several times.To avoid metal seizure, the instructions for reprocessing must be observed.Prior to function checks, lubricate moving parts (e.G.Joints, pusher components an threaded rods) with maintenance oil suitable for the respective sterilization process.

Event Description

It was reported that there was an issue with box locks on the needle holder(s).The devices were not able to be used during an unknown number of procedures.The surgeon stated that it was stiff and difficult to manipulate as intended.A back-up device was used instead.There was no surgical delay or patient harm.It was noted that they were stiff even after lubrication in central processing.The adverse event / malfunction is filed under aag reference: (b)(4).Associated medwatch-reports: 9610612-2020-00628 (400486877 bm024r).

Manufacturer Narrative

Based on the new information: this case was judged to no longer reportable.Associated medwatches: 9610612-2020-00785.9610612-2020-00628.The product was evaluated; after investigation severity changed from 3(5) to 2(5) and reporting obligation updated.Patient injury unknown also changed from yes to no.

Event Description

Based on the new information: this case was judged to no longer reportable.

• Brand Name: TC HALSEY 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: 10837703
• MDR Text Key: 216349325
• Report Number: 9610612-2020-00785
• 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: 12/03/2020

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: BM012R
• Device Catalogue Number: BM012R
• Device Lot Number: 4510773816
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1