MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 5.5MM 45, HD AUTOCLAVABLE LAPAROSCOPE 30CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 0502503045

Device Problems Image Display Error/Artifact (1304); Misfocusing (1401)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a blurry image during the procedure.

Manufacturer Narrative

Alleged failure: cib brandon onsite blurry po# (b)(4).Delay: 2 minutes.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be loose components inside the distal and/or proximal end of the scope causing the image of the scope to become blurry.This may have occurred as a result of rough handling during product transport and/or sterilization.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that there was a blurry image during the procedure.

• Brand Name: PRECISION IDEAL EYES 5.5MM 45, HD AUTOCLAVABLE LAPAROSCOPE 30CM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10213543
• MDR Text Key: 197297307
• Report Number: 0002936485-2020-00251
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327059175
• UDI-Public: 07613327059175
• Combination Product (y/n): N
• PMA/PMN Number: K910132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 0502503045
• Device Catalogue Number: 0502503045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1