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

Model Number BM012R

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

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 product (b)(4).It was reported that there was an issue with a tc halsey needle holder serr 130mm devices were not able to be used during an unknown number of procedures due to having stiff box locks.Reportedly the surgeon would note the device's box lock was stiff causing it to be too sticky, and difficult to manipulate as intended and would grab an alternative, back-up device.The incident did not cause a serious injury, there was no harm to the patients, and no need for any surgical intervention.Alternative devices were readily available as such the incident did not cause or contribute to a surgical delay.This complaint involves a total of four devices.There was no patient harm.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).

Event Description

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

Manufacturer Narrative

Based on the new information: this case was judged to no longer reportable.Associated medwatches: 9610612-2020-00785 and 9610612-2020-00628.(item code, batch and production date updated to tc webster needle holder bm024r, 4510556512, and 5/26/2019.) an evaluation was performed: after investigation, severity changed from 3(5) to 2(5) and reporting obligation changed.

• Brand Name: TC HALSEY NEEDLE HOLDER SERR 130MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10635125
• MDR Text Key: 210000782
• Report Number: 9610612-2020-00628
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/06/2020
• 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