MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 20L HIGH FLOW INSUFFLATOR 100-240V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number PY0620030020E

Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

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

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The gtin is not known at this time.However, should it become available it will be provided in future reports.Filing on behalf of wom (world of medicine).

Event Description

It was reported that the procedure was cancelled.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the high voltage valve in the insufflator has air leak.Probable root cause: the reported event could be not confirmed.There are no indications of a manufacturing issue.Since the device was not returned and no exact information regarding the third-party repair was provided, an exact root-cause analysis is not possible.Based on the event description, a component defect can be assumed.Due to the age of the device, it is assumed that this is due to age-related wear.Insufficient maintenance work can also lead to a component failure.The date of the last pm at a qualified service point is not known.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the procedure was cancelled.

• Brand Name: 20L HIGH FLOW INSUFFLATOR 100-240V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11935742
• MDR Text Key: 254234688
• Report Number: 0002936485-2021-00293
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K955791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PY0620030020E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other