MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TCK1 HD CAMERA HEAD; ENDOSCOPIC VIDEO CAMERA

Catalog Number	242400
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional 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.(b)(6).
Event or Problem Description
It was reported by the affiliate via e-mail that during a cystoscopy the tick1 hd camera head was blank.There was no image after putting it on for few minutes during the surgery.The case was identified intra-op.There was a surgical delay of one hour.There was no patient consequences.The surgeon managed the case and it was completed.There was no alternative product available.
Event or Problem Description
Additional information received from the affiliate reported the surgeon was able to manage the case by using another camera system available.It was reported the distributor has to send a standby camera to the hospital and no surgical intervention was required.The affiliate also reported additional intervention was not required due to the one hour delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: no nonconformances were identified for this part-serial number combination.The complaint device was received at the service center and evaluated.Our affiliate reported an issue of the device had flickering image, and then there was no image.Per evaluation, the device was found to be not working, therefore this complaint can be confirmed.The complaint device was deemed irreparable and hence it will be replaced.With the available information, we cannot determine a root cause of the reported problem.At this point in 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TCK1 HD CAMERA HEAD
• Common Device Name: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8972711
• Report Number: 1221934-2019-58218
• Device Sequence Number: 2022953
• Product Code: FWF
• UDI-Device Identifier: 10886705026258
• UDI-Public: 10886705026258
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 242400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 10/10/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/02/2019; 10/10/2019
• Patient Sequence Number: 1