MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620050010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Liver Laceration(s) (1955)

Event Date 09/27/2018

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 there was an injury to the patient's liver.The injury was repaired.

Manufacturer Narrative

Alleged failure: abrupt pressure collapse.Probable root cause: because a tsr was not provided by oem - wom, probable root cause cannot be determined.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was an injury to the patient's liver.The injury was repaired.

Manufacturer Narrative

This insufflator was not received for evaluation at stryker endoscopy.This insufflator was received at oem-wom for evaluation.Based on the oem-wom service record, the reported failure ¿abrupt pressure collapse¿ was not confirmed.The reported failure mode will be monitored for future reoccurrence.According to wom: visual inspection - the device was received on nov 21, 2018 for evaluation.The device was insufficiently packed and the lower part of the housing is dented/deformed.Functional inspection - functional inspection indicated the returned device passed all criteria.This included a pressure and flow test with a result of pass.Dimensional inspection - due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.The results of the investigation performed indicated that the returned pneumoclear plus c02 conditioning insufflator, catalog#0620050010 rev h, sn (b)(4) is working according to specification.Probable root cause is: the reported event could be not confirmed.There are no indications of a manufacturing issue.

Event Description

It was reported that there was an injury to the patient's liver.The injury was repaired.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8002683
• MDR Text Key: 124948659
• Report Number: 0002936485-2018-00666
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (y/n): N
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2019

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: 0620050010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 09/28/2018; 09/28/2018
• Supplement Dates FDA Received: 01/25/2019; 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR