MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, HYSTEROSCOPE, 2.9MM 12DEG; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 0502729012

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

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 an increased in anesthesia time.

Event Description

It was reported that there was an increased in anesthesia time.

Manufacturer Narrative

This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service record attached, the reported failure "rod broke off from eyepiece" was confirmed.According to henke: scope evaluated as a level 4 (scrap).Tip and fiber damaged, broken lenses in system and needle completely detached.Scope in field for 5+ years.Probably root cause for this failure is: due to customer use and handling.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, HYSTEROSCOPE, 2.9MM 12DEG
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12636556
• MDR Text Key: 279033671
• Report Number: 0002936485-2021-00548
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 07613327059823
• UDI-Public: 07613327059823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502729012
• Device Catalogue Number: 0502729012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1