MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CLARITY CONSOLE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Catalog Number 0240260000

Device Problem Poor Quality Image (1408)

Patient Problem No Code Available (3191)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the image became grainy and had to convert to open surgery.

Manufacturer Narrative

The product was received at stryker endoscopy and was shipped to the legal manufacturer, zmicro for evaluation.The oem investigation report indicates: "analysis summary (attach or reference all relevant information.) 1/18/2019: the reported malfunction does not need to be reported per medical device reporting for manufacturers guidance for industry and food and drug administration staff section 2.14.Updated 2/4/2019: received unit with scratches on chassis and top, no other damages noted.Unable to duplicate reported failure of unit exhibiting video issue.Tested and verified system functionalities.Verified video signal on all in/output sources.Unit requires service object 1804-c1-00101 which consists of various firmware application updates.Unit also requires ground safety label and updated serial label.Updated main controller board 11-93667.00.001 rev.50 32-00214 rev.50 32-00146 rev.50 32-00138 rev.55 updated output board 11-93670.02.001 rev.50 32-00215 rev.50 installed ground safety label (vf route: 32 vn) replaced serial label (vf route: 32 vn) initial test (21-0102tp rev.E 8.3) burn-in test (21-0102tp rev.8.7) final test (21-0102tp rev.8.10) unit functionality tested in accordance with atp test procedure 21-0102tp rev e, section 8.7 burn-in test performed with no failures found.Equipment used in diagnostic and testing of this unit was: dell precision tower 3620 - s/n: (b)(4), cinereoid pattern generator - s/n: (b)(4), 4k display bm230-4k, s/n: (b)(4).The reported symptoms and issue resolution correlate with the symptoms that were investigated on ca0192 and resolved with c1-00099." the failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

Event Description

It was reported that the image became grainy and had to convert to open surgery.

• Brand Name: CLARITY CONSOLE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8224686
• MDR Text Key: 132375573
• Report Number: 0002936485-2019-00009
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00869958000117
• UDI-Public: 00869958000117
• Combination Product (y/n): N
• PMA/PMN Number: K130929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0240260000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other