MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS,UNKNOWN

Catalog Number XXX-SCISSORS

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported that in (b)(6) 2017, during an unspecified laparoscopy, the metzenbaum scissors was used and a chisel broke inside the patient and a metal part/tip was left in the patient.It was reported that the metal part is not from the blade of the scissors, but from the articulated hinge part of the scissor tip.It is unknown if there was any patient injury or a surgical delay.Additional information was received on (b)(6) 2018 stated lot number 308676 corresponds to a tube, cev649-5b dia 5mm 350mm (concomitant product).Additional request for information has been sent.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.The lot number does not correspond to the scissors and the product id is unknown, therefore a dhr review cannot be carried out.The root cause cannot be carried out due to the instrument was not returned and the batch number does not correspond to the metzenbaum scissors.The batch number 308676 declared by the hospital corresponds to the product id cev649-5b.It¿s a tube and not a metzenbaum scissors.

Event Description

N/a.

• Brand Name: SCISSORS,UNKNOWN
• Type of Device: SCISSORS
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 8148941
• MDR Text Key: 129876201
• Report Number: 2523190-2018-00177
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SCISSORS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEV649-5B, TUBE