MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL ARTHSCO,4/140_30_QIK/STRKR HUB; RIGID ENDOSCOPE

Catalog Number 242043

Device Problem Poor Quality Image (1408)

Patient Problem Tissue Damage (2104)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device was received and evaluated at service center.Checked the device and found the image was foggy.No physical "damaged".The complaint is confirmed.Replaced with new scope.At the time of the investigation, the root cause of the failure mode is undetermined.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

It was reported by the affiliate in (b)(6) that in the beginning of an unspecified surgical procedure, it was observed that the vision on arthsco,4/140_30_qik/strkr hub device got foggy.As a result, the original arthroscopic procedure was changed to an open procedure.There was a delay of an hour in the surgical procedure.It was not reported if a spare device was available for use.There was no tissue damage on the patient; however, the patient's status post-surgery was unknown.It was reported that "there" revision surgery / re-operation was not needed.It was not reported if there was a medical intervention nor prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated evaluation statement: the complaint device was received and evaluated at service center.On inspection, it was found that the image was foggy.No physical damaged was found.The complaint is confirmed.Replaced with new scope.At the time of the investigation, the root cause of the failure mode is undetermined.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the records reviewed.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

Event Description

Additional information received from affiliate on 17october2018: it was reported the procedure was completed by doing it open case.Reportedly there was a delay to the procedure, but the length of the delay is unknown.There were no patient consequences.Additional information received from affiliate on 15november2018: reportedly there was no tissue damage.No revision or re-operation was needed.The issue was detected intra-operatively.The patient¿s current status is unknown.The surgery was delayed for one (1) hour.

• Brand Name: ARTHSCO,4/140_30_QIK/STRKR HUB
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8077871
• MDR Text Key: 127374127
• Report Number: 1221934-2018-55320
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705026234
• UDI-Public: 10886705026234
• Combination Product (y/n): N
• PMA/PMN Number: K971996
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2018
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other