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

Model Number 0502503030

Device Problems Poor Quality Image (1408); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

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 procedure.

Manufacturer Narrative

Alleged failure: water spots.Confirmed failure: outer tube damaged (bent, dented),broken rod lens.Probable root cause: improper cleaning process at assembly, loss of in-joint pressure, shipping damage, use error.The product was returned for investigation and the reported failure mode was confirmed.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 procedure.

• Brand Name: PRECISION IDEAL EYES 5.5MM 30, 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: 10534934
• MDR Text Key: 207912656
• Report Number: 0002936485-2020-00383
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327059144
• UDI-Public: 07613327059144
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502503030
• Device Catalogue Number: 0502503030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1