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

Catalog Number	0620050010
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that there was an injury to the patient's liver.The injury was repaired.
Additional 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 or Problem Description
It was reported that there was an injury to the patient's liver.The injury was repaired.
Additional 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 or Problem 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)
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8002683
• Report Number: 0002936485-2018-00666
• Device Sequence Number: 16469119
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 0620050010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 09/28/2018; 09/28/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/25/2019; 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR