MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAONE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number ONB5STF

Device Problems Packaging Problem (3007); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to laparoscopic hysterectomy, when the surgeon inserted 5mm rigid endoscope to the obturator, a crack sound was heard and the obturator broke.The event occurred when the surgeon operated the product out of the surgical field.The procedure was completed with another device.There was no patient involvement.

Manufacturer Narrative

Additional information: d10, g4, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Visual inspection noted that obturator shaft was disengaged from the obturator top and the tabs at the proximal end of the obturator shaft were bent.The cannula, trocar, duckbill and circular seals was not received.It was reported that the obturator was damaged.An associated device issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur as a result of rough handling.It was also reported that that the device gave unexpected or uncharacteristic audible feedback of normal use.An associated device issue could not be confirmed.The most likely root cause could not be established from the information available.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAONE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 10104322
• MDR Text Key: 193129328
• Report Number: 9612501-2020-00776
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521657632
• UDI-Public: 10884521657632
• Combination Product (y/n): N
• PMA/PMN Number: K112349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONB5STF
• Device Catalogue Number: ONB5STF
• Device Lot Number: J9L2561JY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1