MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. NEEDLE HOLDER CEV744T5 DIA 5MM TUNGSTEN; PFM16

Catalog Number CEV744T5

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.The dhr for lot no.3622905 reviewed and no anomalies that could be associated with the complaint were observed.The evaluation verified the complaint as valid.The device doesn't hold the needle, the needle turns.The device has been repaired outside of (b)(4) by an external contractor : (b)(4)".This modification could have led to the reported event.Linked to mfg numbers: 2523190-2020-00036 and 2523190-2020-00038.

Event Description

This is 2 of 3 reports.It was reported that the cev744t5 needle holder cev744t5 dia 5mm tungsten did not tighten/maintain the needle.The needle turned when the surgeon did sutures.The device was not able to be used.Another unit was used with a new pad however, the tightening issue was still observed.The dysfunction led to an increase in surgery time for 20 minutes.Patient was not injured.The surgery was finished by using a replacement needle holder.It was reported that device was used on 2 female patients having a (hysterectomy procedure) and 2 female patients undergoing promontofixation (surgery to treat genitourinary prolapse).The patients were between 40 and 60 years old.

• Brand Name: NEEDLE HOLDER CEV744T5 DIA 5MM TUNGSTEN
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10279481
• MDR Text Key: 203352997
• Report Number: 2523190-2020-00037
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV744T5
• Device Lot Number: 3622905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1